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Insights on product development, quality management, and regulatory compliance for teams building life-saving products.

Episodic vs. Continuous Readiness: Which Operating Model Is Carrying Your Biotech Forward?
Biotech

Episodic vs. Continuous Readiness: Which Operating Model Is Carrying Your Biotech Forward?

Most growth-stage biotech companies are audit-ready. Far fewer are scale-ready. Learn the difference between episodic and continuous readiness — and why it determines your clinical outcomes.

QualioMay 11, 2026
CDSCO Medical Device Registration in India: What's Changed in 2026 (And What Still Applies)
Compliance

CDSCO Medical Device Registration in India: What's Changed in 2026 (And What Still Applies)

CDSCO has moved fast since 2024. This 2026 update covers new SaMD software guidance, three FAQ addenda, post-approval change clarity, and the BIS Scheme X deadline — everything you need before entering the Indian medical device market.

Sumatha Kondabolu
Sumatha KondaboluMay 7, 2026
The Structural Limits of Generic GRC in Modern Life Sciences
Medical Devices

The Structural Limits of Generic GRC in Modern Life Sciences

Generic GRC platforms were built for corporate risk — not regulated product lifecycles. Learn why life sciences organizations outgrow them, and what a purpose-built compliance architecture actually looks like.

QualioMay 6, 2026
Regulation Is Not Slowing Your Medical Device. Your Compliance Architecture Is.
Medical Devices

Regulation Is Not Slowing Your Medical Device. Your Compliance Architecture Is.

FDA oversight isn't why MedTech product development slows down. Fragmented compliance architecture is. Here's what that costs—and what a better system looks like.

QualioMay 4, 2026
The Work That Never Shows Up in Your QA Plan
Quality Management

The Work That Never Shows Up in Your QA Plan

Most biotech QA teams aren't short on people, they're short on capacity. Learn where the hours actually go, and what it's costing your clinical program.

QualioApr 29, 2026
MDSAP Unlocked: What Quality and Regulatory Professionals Need to Know to Build a Certification-Ready QMS
eQMS

MDSAP Unlocked: What Quality and Regulatory Professionals Need to Know to Build a Certification-Ready QMS

Learn how to prepare your quality management system for MDSAP certification across all five jurisdictions, from audit structure to what inspectors actually look for.

Sumatha Kondabolu
Sumatha KondaboluApr 27, 2026
503A vs 503B
Compliance

503A vs 503B: Turning Regulatory Complexity into Practical Compliance

Navigating the differences between 503A and 503B compounding regulations doesn't have to be overwhelming. Here's what your organization needs to know to build a compliant, inspection-ready quality system.

Sumatha Kondabolu
Sumatha KondaboluApr 20, 2026
Blog1
Biotech

Why Generic GRC Fails Biotech — And What the Architecture Should Actually Look Like

Generic GRC platforms were built for corporate risk — not regulated product lifecycles. Learn why biotech organizations outgrow them, and what a purpose-built compliance architecture actually looks like.

QualioApr 17, 2026
Fragmentation in biotech compliance
Biotech

The Compliance Tax Biotech Companies Keep Paying, And Do Not Recognize.

Fragmentation in biotech compliance does not announce itself. It accumulates quietly, buried in normal operations and unseen until it disrupts.

QualioApr 15, 2026
The Readiness Paradox: Why Audit Success Does Not Guarantee Clinical‑Stage Readiness in Biotech
Biotech

The Readiness Paradox: Why Audit Success Does Not Guarantee Clinical‑Stage Readiness in Biotech

Learn why passing audits does not equal clinical‑stage readiness in biotech. Discover hidden costs when readiness breaks down and how to build a continuous system.

QualioApr 14, 2026
White column with hairline crack
Biotech

Your Compliance Model: Effective Now, Vulnerable Later

Your biotech compliance model is passing audits. That's not the same as being ready for what's next. Here's when and why manual models quietly break.

QualioApr 10, 2026
Audit-Ready vs Scale-Ready: Why Passing Is Not Proof
Medical Devices

Audit-Ready vs Scale-Ready: Why Passing Is Not Proof

Discover how MedTech companies can shift from episodic audit readiness to scalable, continuous compliance to ensure sustainable growth and operational success.

QualioApr 9, 2026
Continuous Readiness Is Becoming the New Operating Standard in MedTech
Medical Devices

Continuous Readiness Is Becoming the New Operating Standard in MedTech

Medical device companies can no longer rely on episodic audit prep. Learn why continuous readiness is becoming the new operating standard in MedTech, and what it means for QMS, FDA inspection readiness, and regulatory timelines.

QualioApr 6, 2026
Mastering QMSR: Key Takeaways and Strategies
Medical Devices

Mastering QMSR: Key Takeaways and Strategies

Move beyond checkbox compliance. Explore expert insights on QMSR, proactive supplier management, and building a continuous quality management system.

QualioMar 25, 2026
Continuous readiness is becoming the new operating standard in medtech
Medical Devices

Continuous readiness is becoming the new operating standard in medtech

Discover why continuous readiness, not episodic audit preparation, is essential for modern medtech compliance and regulatory success.

Jim LefevereFeb 27, 2026
The structural limits of generic GRC in modern life sciences
Compliance

The structural limits of generic GRC in modern life sciences

Life science companies face compliance challenges from outdated GRC models. Learn how to optimize your audit readiness and operational predictability with the latest best practice.

Jim LefevereFeb 26, 2026
Regulation isn't slowing your medical device. Fragmentation is.
Medical Devices

Regulation isn't slowing your medical device. Fragmentation is.

Fragmented quality systems, not regulations, are the real cause of delays in medical device development. Learn how continuous compliance can streamline your regulatory process.

Jim LefevereFeb 20, 2026
If compliance is slowing you down, your regulations are not the problem. Your model is.
Medical Devices

If compliance is slowing you down, your regulations are not the problem. Your model is.

For medical device companies, a unified, continuous compliance architecture is the key to optimizing speed and efficiency — without compromising regulatory rigor.

Jim LefevereFeb 18, 2026
What is the FDA QMSR?
Medical Devices

What is the FDA QMSR?

The FDA plans to align 21 CFR 820 and ISO 13485. There are a number of steps that will be taken to achieve harmonization — here's what you need to know.

Sumatha Kondabolu
Sumatha KondaboluJan 12, 2026
How AI is reshaping pharmacovigilance: key takeaways from the new CIOMS report
Pharmaceutical

How AI is reshaping pharmacovigilance: key takeaways from the new CIOMS report

Discover how AI is revolutionizing pharmacovigilance with our insights and takeaways from the 2025 CIOMS report.

Sumatha Kondabolu
Sumatha KondaboluDec 12, 2025
Top 10 conferences for life science companies in 2026
Compliance

Top 10 conferences for life science companies in 2026

Looking for the top life science conferences in 2026? Check out our curated list of industry events for pharma, med device and biotech professionals.

Meg SinclairDec 10, 2025
8 ways to fail an ISO audit in 2026
ISO 9001

8 ways to fail an ISO audit in 2026

Don't let an ISO audit scare you. Learn from these mistakes so you can prepare and pass an ISO audit this year.

Meg SinclairDec 9, 2025
25 impressive medical device startups to watch in 2026
Medical Devices

25 impressive medical device startups to watch in 2026

Get the full list of medical device companies who are shaping the industry this year. Wonderful inventions, lifesaving products, and more.

Lola FurlongDec 9, 2025
5 secrets to securing medical device venture capital in 2026
eQMS

5 secrets to securing medical device venture capital in 2026

Digging for venture capital funding for your medical device company this year? Learn our 5 secrets for maximizing your chance of success.

Meg SinclairDec 8, 2025
5 tips for pitching your life science company to investors in 2026
Funding

5 tips for pitching your life science company to investors in 2026

Walking into the room to pitch your life science company or product to investors can be the defining moment of your career. We've put together 5 tips to help.

Alex PavlovićDec 8, 2025
5 tips for planning your quality management budget in 2026
Quality management

5 tips for planning your quality management budget in 2026

Quality management needs careful, considered budgeting for maximum impact. Learn our 5 top tips for putting your budget together.

Alex PavlovićDec 5, 2025
Introduction to quality control software
eQMS

Introduction to quality control software

Discover how quality control software enhances compliance and operational efficiency for life science companies.

Alex PavlovićDec 3, 2025
8 benefits of a quality management system (QMS) in 2026
Quality management

8 benefits of a quality management system (QMS) in 2026

Discover the key benefits of a quality management system, its importance, and how it enhances organizational efficiency. Learn more here.

Jerry AdatsiDec 3, 2025
Complete guide to computer system validation in 2026
Computerized System Assurance

Complete guide to computer system validation in 2026

Do you know your CSA from your CSV? Still battling with IQs, OQs and PQs? Need a steer on GAMP? Our guide demystifies the complex world of validation.

Alex PavlovićDec 2, 2025
Pharmaceutical quality management software (QMS): our top picks for 2026
Pharmaceutical

Pharmaceutical quality management software (QMS): our top picks for 2026

Looking to upgrade your pharmaceutical quality system by investing in QMS software? Use our breakdown comparison guide to make the right choice.

Lola FurlongDec 1, 2025
What to know about document control software in 2026
Document Control

What to know about document control software in 2026

Explore the best document control software for life sciences. Read reviews about the best document version control software.

Meg SinclairDec 1, 2025
2026 guide to pharmaceutical software
Pharmaceutical

2026 guide to pharmaceutical software

Learn everything you should know about pharmaceutical software in 2024, including top tools, benefits and trends.

Alex PavlovićNov 29, 2025
Essential ISO software features for life science GRC
Compliance

Essential ISO software features for life science GRC

Discover the key ISO software features that optimize compliance for life science companies, ensuring audit readiness and unlocking continuous improvement.

Alex PavlovićNov 20, 2025
A complete guide to 21 CFR Part 11 for medical device manufacturers
Medical Devices

A complete guide to 21 CFR Part 11 for medical device manufacturers

21 CFR Part 11 governs electronic records & electronic signatures. Learn what medical device manufacturers must know about 21 CFR Part 11 to be compliant.

Meg SinclairNov 19, 2025
Mastering quality management in laboratory environments: 12 essential techniques for 2026
Quality Systems

Mastering quality management in laboratory environments: 12 essential techniques for 2026

This comprehensive guide explores the 12 essential techniques for quality management in laboratory environments - whether you're a laboratory professional or a quality manager!

Lola FurlongNov 19, 2025
Why pharmaceutical regulatory compliance software is essential for biopharma companies
Compliance

Why pharmaceutical regulatory compliance software is essential for biopharma companies

Discover how pharmaceutical regulatory compliance software simplifies compliance, embeds audit readiness and accelerates growth for biopharma companies.

Alex PavlovićNov 13, 2025
What do the FDA's CSA guidelines mean?
Computerized System Assurance

What do the FDA's CSA guidelines mean?

The FDA revealed its long-awaited computerized system assurance guidelines in September 2022. We dove in to find out what they mean for your business.

Alex PavlovićNov 12, 2025
What is ISO 15189? A complete overview
ISO 15189

What is ISO 15189? A complete overview

Understand ISO 15189 and its impact on quality management in medical laboratories. Unpick ISO 15189’s requirements and embed lasting compliance.

Molly CalveyNov 10, 2025
What's the best regulatory compliance management software for life science companies?
Compliance

What's the best regulatory compliance management software for life science companies?

Discover the importance of regulatory compliance management software in life sciences, and explore the top platforms to maximize your compliance health

Alex PavlovićNov 6, 2025
What's the best eQMS software in 2026?
eQMS

What's the best eQMS software in 2026?

Discover the top eQMS software systems for 2025. Compare features and reviews to find the best electronic quality management system for your needs.

Sumatha Kondabolu
Sumatha KondaboluNov 4, 2025
Your complete guide to the Medical Device Single Audit Program (MDSAP)
Medical Devices

Your complete guide to the Medical Device Single Audit Program (MDSAP)

Learn how the Medical Device Single Audit Program (MDSAP) streamlines regulatory compliance for five major markets, with tips for certification and preparation strategies.

Alex PavlovićSep 19, 2025
Announcing: Compliance Intelligence
Compliance

Announcing: Compliance Intelligence

Introducing Compliance Intelligence: a new compliance platform by Qualio that transforms compliance from bottleneck to growth accelerator for life science companies.

Alex PavlovićSep 16, 2025
Ultimate guide to the EU IVDR: everything you need to know
IVDR

Ultimate guide to the EU IVDR: everything you need to know

Learn everything you need to know about the EU IVDR, its requirements, and how to ensure compliance for your in vitro diagnostic medical devices.

Alex PavlovićAug 26, 2025
Overview of ISO 14155
Medical Devices

Overview of ISO 14155

Discover how ISO 14155:2020 ensures ethical compliance and scientific validity in clinical investigations for medical devices. Learn key requirements and best practices for certification.

Alex PavlovićJul 17, 2025
Good Manufacturing Practices (GMP) explained
GxP

Good Manufacturing Practices (GMP) explained

Learn the importance of Good Manufacturing Practice (GMP) in life science for ensuring product quality and compliance.

Alex PavlovićJul 2, 2025
All about GMP labeling: requirements and best practices
GxP

All about GMP labeling: requirements and best practices

Understand the key requirements of GMP labeling and meet best labeling practice for your regulated life science products.

Alex PavlovićJul 2, 2025
The complete guide to the ICH Q7 guidelines
Pharmaceutical

The complete guide to the ICH Q7 guidelines

Learn how to meet ICH Q7 guidelines for API manufacturing to ensure optimal quality and compliance in your pharmaceutical company.

Alex PavlovićJun 30, 2025
Transforming design controls in our new Qualio upgrade
eQMS

Transforming design controls in our new Qualio upgrade

Qualio's latest upgrade enhances your design controls with improved traceability, flexibility and ease of use for your life science product development.

Tina KarimiJun 12, 2025
Ultimate guide to the IEC 62304 standard
Medical Devices

Ultimate guide to the IEC 62304 standard

Learn everything about IEC 62304, the essential standard for medical device software development, from certification steps to practical implementation tips.

Alex PavlovićMay 30, 2025
What is EDMS software?
Document Control

What is EDMS software?

Learn how EDMS software can transform document management for your business, offering features like version control, e-signatures and audit trails to ensure compliance and efficiency.

Alex PavlovićMay 8, 2025
Kicking off 2025 with more integrations and deeper data connections for Qualio customers
eQMS

Kicking off 2025 with more integrations and deeper data connections for Qualio customers

Discover Qualio's latest eQMS updates, including new integrations, enhanced data management and improved usability to streamline your quality processes.

Tina KarimiMar 13, 2025
What is ICH E6 R3? Good clinical practice explained
ICH

What is ICH E6 R3? Good clinical practice explained

Get the full overview of ICH E6 (R2), the international standard for good clinical practice, and learn what you need to comply.

Lola FurlongMar 13, 2025
The ultimate ISO 9001 overview: quality management systems
ISO 9001

The ultimate ISO 9001 overview: quality management systems

The ISO 9001 standard maps out the model for a modern, effective quality management system (QMS). Learn about all the elements of ISO 9001.

Alex PavlovićMar 13, 2025
CureMetrix helps radiologists make better, faster decisions with AI
eQMS

CureMetrix helps radiologists make better, faster decisions with AI

CEO Robert Fenton and Sam Dribin, CTO of CureMetrix, talk about how the technology company is using AI and medical imaging to improve healthcare for women.

Teena HartJan 29, 2025
Kicking off 2025 with new G2 accolades from our customers
eQMS

Kicking off 2025 with new G2 accolades from our customers

We're starting 2025 the right way: with fresh G2 badges and accolades from our happy customers! Check out what we won here.

Alex PavlovićJan 22, 2025
The 3 FDA medical device classes: differences and examples explained
FDA

The 3 FDA medical device classes: differences and examples explained

Learn about the 3 FDA medical device classes. We give comprehensive definitions, examples, and differences of Class I, II, and III devices.

Sumatha Kondabolu
Sumatha KondaboluJan 14, 2025
Quality assurance vs. quality control explained: 5 key differences
Quality management

Quality assurance vs. quality control explained: 5 key differences

Learn about the key quality assurance vs quality control (QA vs QC) differences, and how to apply both disciplines to your operation.

Lola FurlongJan 13, 2025
Qualio leaps to the front of the pack in integrated eQMS providers
eQMS

Qualio leaps to the front of the pack in integrated eQMS providers

Our December 2024 product upgrade gives our customers unparalleled integration and flexibility for their vital quality processes. Learn what we did!

Tina KarimiDec 13, 2024
5 fundamentals of the CAPA quality process
eQMS

5 fundamentals of the CAPA quality process

Get a comprehensive understanding of the CAPA quality process. Learn how to identify root causes of compliance issues and avoid mistakes.

Meg SinclairDec 4, 2024
Understanding post-market surveillance for medical devices
Medical Devices

Understanding post-market surveillance for medical devices

Post-market surveillance (PMS) helps you capture feedback about your medical device. Learn how to create a PMS plan and run a successful post-market surveillance program.

Sumatha Kondabolu
Sumatha KondaboluDec 4, 2024
What you should know about the CE mark
Compliance

What you should know about the CE mark

The CE mark certifies that your product meets EU safety, health and environmental standards. Learn the essentials about CE marking, and how to secure yours.

Alex PavlovićOct 29, 2024
What you should know about UKCA marking
Compliance

What you should know about UKCA marking

Learn all about the UKCA mark, its requirements, and how businesses can ensure compliance with post-Brexit product regulations in the UK.

Alex PavlovićOct 21, 2024
The role of CAPA in pharma
Pharmaceutical

The role of CAPA in pharma

Learn the essentials of CAPA in pharma, from corrective actions to preventive strategies, and how pharma quality managers can ensure total CAPA compliance.

Alex PavlovićOct 17, 2024
Q-Pulse vs. Qualio: a comprehensive guide to eQMS for life science companies
eQMS

Q-Pulse vs. Qualio: a comprehensive guide to eQMS for life science companies

Explore a comprehensive comparison of the Q-Pulse and Qualio eQMS platforms, focusing on features, user feedback, and suitability for different organizational needs.

Jerry AdatsiSep 24, 2024
Qualio named Top Compliance Software for 2024
eQMS

Qualio named Top Compliance Software for 2024

Qualio secured a spot on Tekpon's Top Compliance Software list for 2024, recognized for our functionality, strong customer reviews and compliance support.

Alex PavlovićSep 23, 2024
ISO 13485: the essential guide
Medical Devices

ISO 13485: the essential guide

Review the key elements of ISO 13485 and how to successfully prepare for ISO 13485 certification.

Sumatha Kondabolu
Sumatha KondaboluSep 18, 2024
What is a quality management system (QMS)?
Quality management

What is a quality management system (QMS)?

What is a quality management system? In a nutshell, it's your company's key to success. Read our breakdown of what a QMS is, and why you need one ASAP!

Jerry AdatsiSep 17, 2024
5 things we learned at the PDA/FDA Joint Regulatory Conference 2024
FDA

5 things we learned at the PDA/FDA Joint Regulatory Conference 2024

We headed to Washington to get the latest pharma and biotech quality news straight from the PDA/FDA joint regulatory conference! Here's what we learned.

Alex PavlovićSep 17, 2024
Our biggest product upgrade yet: UX, AI and more!
eQMS

Our biggest product upgrade yet: UX, AI and more!

Qualio's biggest-ever update overhauls the system UX, adds AI, builds deeper connections between your vital quality data, and more. Take a look what we did!

Emma HanleySep 3, 2024
How to double your ISO 13485 certification speed with Qualio
Case Studies

How to double your ISO 13485 certification speed with Qualio

Cardiaccs needed ISO 13485 certification - fast - as well as a new quality management system to get them there. With Qualio, they hit both objectives.

Alex PavlovićAug 29, 2024
Ultimate guide to Qualio integrations
Integrations

Ultimate guide to Qualio integrations

Learn how we've designed Qualio's integrations to connect your business-critical systems, break down barriers and make quality and compliance simple.

Emma HanleyAug 20, 2024
What are the differences between quality management, quality control and quality assurance?
Quality management

What are the differences between quality management, quality control and quality assurance?

Discover the key differences between quality management, quality control, and quality assurance with Qualio. Learn which approach best suits your needs.

Alex PavlovićJul 18, 2024
A guide to writing corrective and preventive action (CAPA) reports
Compliance

A guide to writing corrective and preventive action (CAPA) reports

Learn how to write effective CAPA reports with our guide. Discover templates, examples, and essential tips for corrective and preventive actions.

Meg SinclairJul 9, 2024
What is design control for medical devices and how does it work?
Medical Devices

What is design control for medical devices and how does it work?

Discover how design control ensures quality in medical devices. Learn about FDA guidance, documentation, and the design control process flow chart.

Sumatha Kondabolu
Sumatha KondaboluJul 9, 2024
Faster, streamlined quality processes powered by AI in Qualio
eQMS

Faster, streamlined quality processes powered by AI in Qualio

Discover how Qualio's AI upgrade revolutionizes your quality processes. Faster document editing, change summaries and training assessments, without effort.

Emma HanleyJul 5, 2024
What is total quality management (TQM) and how does it differ from a QMS?
Quality management

What is total quality management (TQM) and how does it differ from a QMS?

Explore how Total Quality Management (TQM) enhances modern life science companies. Discover key principles, examples and how it differs from a regular QMS.

Alex PavlovićJun 25, 2024
How to develop and implement a quality management system (QMS)
Quality management

How to develop and implement a quality management system (QMS)

Discover how to develop and implement a QMS with Qualio. Learn key steps to create, set up, and audit your quality management system effectively.

Alex PavlovićJun 20, 2024
What is Corrective Action Preventive Action (CAPA)?
Compliance

What is Corrective Action Preventive Action (CAPA)?

Explore the CAPA definition, its importance in quality assurance, and real-world CAPA examples. Learn what CAPA stands for and its role in manufacturing.

Lola FurlongJun 14, 2024
Advancing the Qualio Way by cutting the stress from change management and simplifying custom event visibility and tracking
eQMS

Advancing the Qualio Way by cutting the stress from change management and simplifying custom event visibility and tracking

We're making collaboration and data analysis even more intuitive and simple for our customers in our latest Launch Train. Learn what's new.

Todd WilkensJun 10, 2024
How to build a complaint management system
Compliance

How to build a complaint management system

Learn about the steps to take to create a complaint management system, and how to choose a complaint management software to automate complaint management.

Jodi HutchinsJun 3, 2024
CDSCO registration: how to bring your medical device to India
Compliance

CDSCO registration: how to bring your medical device to India

The CDSCO is the gatekeeper of one of the world's fastest-growing medical device markets: India. Learn how to get your medical device into the subcontinent.

Sumatha Kondabolu
Sumatha KondaboluMay 30, 2024
The ultimate guide to change control for life sciences companies
Compliance

The ultimate guide to change control for life sciences companies

Change control is a key part of your QMS. Learn how to write your own change control procedure for a change control process that's compliant and comprehensive.

Molly CalveyMay 29, 2024
The complete guide to SaMD (software as a medical device)
SaMD

The complete guide to SaMD (software as a medical device)

Software as a medical device is software that helps diagnose, treat or manage disease. Review SaMD examples and regulations that govern SaMD development.

Sumatha Kondabolu
Sumatha KondaboluMay 20, 2024
How to Manage the Med Device Software Development Process in Your eQMS
eQMS

How to Manage the Med Device Software Development Process in Your eQMS

Managing the medical device software development process is a big undertaking.

Jerry AdatsiMay 15, 2024
Navigating climate change: updates to ISO certification standards
ISO 9001

Navigating climate change: updates to ISO certification standards

It isn't just the climate that's changing. ISO's 2024 update brings climate change into the heart of your quality management system planning. Learn what's new.

Sumatha Kondabolu
Sumatha KondaboluMay 13, 2024
What the FDA's MDDS guidance means for you
Medical Devices

What the FDA's MDDS guidance means for you

Things have changed since the FDA's Medical Device Data Systems (MDDS) Rule in 2011. The 2022 guidance changes how MDDS are defined and regulated in the medical world.

Sumatha Kondabolu
Sumatha KondaboluMay 8, 2024
The EU AI Act: what to expect
Compliance

The EU AI Act: what to expect

Learn about the upcoming EU AI Act and its implications for life science companies. Get ready for fresh regulatory requirements coming in June 2024.

Lola FurlongMay 8, 2024
The top 10 life science quality assurance consultants to work with in 2024
Medical Devices

The top 10 life science quality assurance consultants to work with in 2024

Need a life science quality expert on your side? We've assembled a crack team of the finest consultants to support your business in 2024.

Alex PavlovićMay 2, 2024
The 9 top medical device consulting firms you should consider for 2024
Medical Devices

The 9 top medical device consulting firms you should consider for 2024

We've hunted the top medical device consulting firms for 2024. Dive into the expert teams that can lift your medical device company to the next level.

Alex PavlovićMay 1, 2024
The top 8 pharmaceutical consulting firms you should consider for 2024
Pharmaceutical

The top 8 pharmaceutical consulting firms you should consider for 2024

Thinking of getting a pharmaceutical consulting firm on your side this year? Look no further than our list of the top 8 seasoned, expert teams for 2024.

Alex PavlovićMay 1, 2024
Life science quality management system: 5 must-have features
Quality management

Life science quality management system: 5 must-have features

Discover key strategies in quality management for life sciences. Learn how a robust QMS enhances compliance and efficiency in the industry.

Emma HanleyApr 17, 2024
Catalyst Awards 2024: the 17 most exciting life science start-ups and scale-ups to watch this year
Industry Awards

Catalyst Awards 2024: the 17 most exciting life science start-ups and scale-ups to watch this year

Discover the top 17 most innovative life science start-ups and scale-ups of 2024. From bone regeneration to AI-driven diagnostics, stay ahead with these groundbreaking companies.

Alex PavlovićApr 2, 2024
How to get an ISO 17025 certification
ISO 17025

How to get an ISO 17025 certification

Learn how to obtain ISO 17025 certification for your testing or calibration laboratory. Follow these steps and ensure your lab's competence.

Lola FurlongMar 22, 2024
9 core elements of a quality management system [Examples]
eQMS

9 core elements of a quality management system [Examples]

Learn everything you need to know about a quality management system (QMS) and how to implement its core elements, so your QMS is compliant and successful.

Jerry AdatsiMar 21, 2024
The 13 Essentials of a Quality Plan for Medical Device Companies
Medical Devices

The 13 Essentials of a Quality Plan for Medical Device Companies

Crafting a quality plan for medical device companies is difficult, and it must contain these 13 essentials if you want to make sure you avoid...

Lola FurlongMar 20, 2024
14 medical device quality management system requirements for regulatory compliance
Medical Devices

14 medical device quality management system requirements for regulatory compliance

By understanding the medical device quality management system requirements for regulatory compliance, you'll be ready to help keep your company off...

Molly CalveyMar 20, 2024
What to look for in quality management consulting services in 2024
Quality-Driven

What to look for in quality management consulting services in 2024

Find out what factors to look out for when looking for Quality management consulting services

Sumatha Kondabolu
Sumatha KondaboluMar 18, 2024
What to look for in quality management consulting services in 2024
Quality-Driven

What to look for in quality management consulting services in 2024

Find out what factors to look out for when looking for Quality management consulting services

Sumatha Kondabolu
Sumatha KondaboluMar 18, 2024
Reinventing eQMS document management (and more!) in our biggest product release yet
eQMS

Reinventing eQMS document management (and more!) in our biggest product release yet

Our biggest product release yet sees a key integration, fresh features, and brand-new system linkages to push our ease of use and collaboration to the max. Learn more in our February 2024 launch review.

Emma HanleyMar 14, 2024
How to choose ISO 13485 QMS software in 2026
ISO 13485

How to choose ISO 13485 QMS software in 2026

Learn how to evaluate the best ISO 13485 compliant software for quality management system compliance and at your medical device company.

Robert FentonMar 13, 2024
CAPA management software: benefits, top features, and how to select the best
eQMS

CAPA management software: benefits, top features, and how to select the best

Discover the top advantages of CAPA system software in 2024 and find the best solutions to enhance your quality management processes.

Meg SinclairMar 4, 2024
How to solve the four most common quality management issues in 2024
Quality Systems

How to solve the four most common quality management issues in 2024

FDA Form 483 data throws a handy spotlight on the most common quality issues medical device companies run into. We looked at the top 4 - and how to avoid them.

Meg SinclairJan 5, 2024
8 best ISO 13485 training programs in 2024
Medical Devices

8 best ISO 13485 training programs in 2024

Searching for the best ISO 13485 training? These top ISO 13485 training programs will help you improve quality processes at your medical device company.

Lola FurlongJan 5, 2024
What Are The 7 best online quality management training courses for 2024?
Quality management

What Are The 7 best online quality management training courses for 2024?

Learn about the 7 best online quality management training courses can help your life sciences companies

Meg SinclairJan 5, 2024
What are the 5 best options for nonconformance management software in 2024?
eQMS

What are the 5 best options for nonconformance management software in 2024?

Looking to invest in nonconformance management software? Learn more about the 5 best choices for your company this year.

Jason MarchJan 5, 2024
A comprehensive review of the best 21 CFR Part 11 software in 2024
21 CFR Part 11

A comprehensive review of the best 21 CFR Part 11 software in 2024

What's the best 21 CFR Part 11-compliant software for your life science company? Learn about 21 CFR Part 11 software compliance and see our list of best vendors.

Sumatha Kondabolu
Sumatha KondaboluJan 5, 2024
How Much Is the FDA Medical Device Registration Fee in 2024?
Medical Devices

How Much Is the FDA Medical Device Registration Fee in 2024?

The FDA medical device user fee for 2022 is $5,672. However, there are other fees medical device manufacturers should be aware of in 2022 and beyond.

Sumatha Kondabolu
Sumatha KondaboluJan 5, 2024
Making work even easier for our customers in our November Launch Train
eQMS

Making work even easier for our customers in our November Launch Train

New file formats, faster validation, a brand-new event editing experience and more. Learn how we made Qualio even better in our November 2023 Launch Train!

Emma HanleyDec 7, 2023
Top pharma conferences in 2024
Pharmaceutical

Top pharma conferences in 2024

Attend the best pharmaceutical conferences in 2024 for pharma industry education and networking opportunities.

Jerry AdatsiDec 1, 2023
The ultimate guide to pharmaceutical quality assurance
Quality Systems

The ultimate guide to pharmaceutical quality assurance

Review the scope of quality assurance in the pharmaceutical industry, including responsibilities and expectations of pharma QA teams.

Meg SinclairNov 22, 2023
6 strategies for successful biotech funding
Biotech

6 strategies for successful biotech funding

Biotech founders use funding strategies like venture capital, grant applications and research partnerships. Learn more about biotech funding strategies.

Robert FentonNov 8, 2023
Understanding the major pharmaceutical regulations you need to know
Pharmaceutical

Understanding the major pharmaceutical regulations you need to know

Review the key pharmaceutical regulations you need to know and understand how they shape quality in the pharmaceutical industry.

Molly CalveyNov 7, 2023
I'm Qualio's chief product officer. Here's what the future of our software looks like.
Company news

I'm Qualio's chief product officer. Here's what the future of our software looks like.

Chief Product Officer Todd Wilkens joined Qualio in 2023 after a string of product leadership roles across the software world. Todd shared his product philosophy and his big plans for Qualio on our blog.

Todd WilkensNov 2, 2023
Good distribution practice: understanding GDP compliance
GxP

Good distribution practice: understanding GDP compliance

Explore the principles of Good Distribution Practice (GDP) in the pharmaceutical industry, ensuring quality and regulatory compliance in distribution.

Jerry AdatsiNov 1, 2023
How much does ISO 9001 certification cost?
ISO 9001

How much does ISO 9001 certification cost?

Are you a life science company chasing ISO 9001 certification? Learn all about the cost of getting ISO 9001 certified.

Lola FurlongOct 16, 2023
Everything you need to know about the FDA 510(k) submission
510(k)

Everything you need to know about the FDA 510(k) submission

Almost half of all US medical devices pass through the 510(k) process. We've built the ultimate guide of everything you need to get your device to market.

Alex PavlovićOct 13, 2023
Best life science vendor, best usability, best set-up, best results! Qualio at G2 Fall 2023
Company news

Best life science vendor, best usability, best set-up, best results! Qualio at G2 Fall 2023

G2's results are in - and Qualio officially offers the best relationship, usability, set-up and real results of any life science eQMS vendor! Learn more here.

Alex PavlovićSep 13, 2023
Fresh features and time-saving shortcuts in our latest product release
eQMS

Fresh features and time-saving shortcuts in our latest product release

Our July Launch Train brings a host of time-saving and effort-erasing features and tweaks to make our customers' lives even easier. Here's what's coming!

Emma HanleyAug 10, 2023
PMA submissions: 4 PMA application methods for medical devices
FDA

PMA submissions: 4 PMA application methods for medical devices

Learn the key steps of the FDA's Pre-Market Approval (PMA) submission process and the different types of PMA applications for your medical device.

Meg SinclairAug 9, 2023
Guide to 21 CFR Part 11 compliance [free checklist]
FDA

Guide to 21 CFR Part 11 compliance [free checklist]

FDA 21 CFR Part 11 compliance is a crucial requirement for regulated companies. Learn how to comply by giving yourself airtight control of your electronic records and signatures.

Meg SinclairJul 20, 2023
PMA meaning: understanding FDA pre-market approval
FDA

PMA meaning: understanding FDA pre-market approval

Learn what you need to know about the rigorous FDA PMA process including preparing data, documentation and more.

Jerry AdatsiJul 19, 2023
What is GxP in pharma?
GxP

What is GxP in pharma?

Explore the fundamentals of GxP in pharmaceutical settings and learn how to maintain compliance with GxP standards.

Lisa HelmondsJul 11, 2023
21 CFR Part 820: the complete overview
FDA

21 CFR Part 820: the complete overview

Find out everything you need to know to comply with FDA 21 CFR Part 820, the FDA's quality system requirements for medical devices.

Sumatha Kondabolu
Sumatha KondaboluJul 3, 2023
Guide to ICH E6 (R3): changes and preparation
ICH

Guide to ICH E6 (R3): changes and preparation

Review the latest GCP guidelines coming in ICH E6 (R3). Learn what's changing and how to prepare your team.

Lola FurlongJun 30, 2023
The hidden costs of a free quality management system
Quality management

The hidden costs of a free quality management system

Thinking of running a free quality management system with paper, email and SharePoint? Think again. Learn why 'free' quality management system tools are anything but.

Sumatha Kondabolu
Sumatha KondaboluJun 26, 2023
Summer of customer love: more Qualio accolades at the G2 Summer Awards
Company news

Summer of customer love: more Qualio accolades at the G2 Summer Awards

Our customers crowned us winners in a range of G2 awards this summer, including naming us the most user-friendly eQMS software on the market! Learn more here.

Alex PavlovićJun 23, 2023
Powerful quality analytic insights in our latest product launch
eQMS

Powerful quality analytic insights in our latest product launch

Our new Analytics area unlocks powerful visibility of your quality system, from document trends to event root causes. Learn more in our showcase blog post.

Emma HanleyJun 14, 2023
What is quality assurance?
Quality management

What is quality assurance?

Learn what quality assurance is, how to build a robust QA process, and how quality assurance can lift your business to the next level.

Jodi HutchinsJun 9, 2023
The TGA's essential principles explained
Medical Devices

The TGA's essential principles explained

Looking to get your medical device into Australia? Learn about the Therapeutic Goods Administration's 'essential principles' and how to embed them.

Sumatha Kondabolu
Sumatha KondaboluMay 24, 2023
What you need to know about ICH Q8
ICH

What you need to know about ICH Q8

Review the fundamentals of ICH Q8 and its significance in drug development. Learn why ICH Q8 compliance is vital for quality-centric pharma companies.

Molly CalveyMay 17, 2023
ICH Q9 quality risk management: an introduction
ICH

ICH Q9 quality risk management: an introduction

Master the building blocks of ICH Q9 quality risk management with our breakdown guide, from risk assessment and control to communication and review.

Molly CalveyMay 15, 2023
The complete guide to passing ISO 13485 audits
Medical Devices

The complete guide to passing ISO 13485 audits

Learn how to prepare for and pass ISO 13485 audits. Get top tips to ensure your medical device company meets all requirements for passing an ISO 13485 audit.

Sumatha Kondabolu
Sumatha KondaboluMay 10, 2023
Top 6 conferences in Australia for life science companies in 2023
Medical Devices

Top 6 conferences in Australia for life science companies in 2023

Australia is a vibrant and emerging life science market. Keep your finger on the pulse with our pick of the 6 key industry conferences to be at in 2023!

Lindsay OremApr 26, 2023
What you need to know about FDA 21 CFR Part 211
GxP

What you need to know about FDA 21 CFR Part 211

FDA 21 CFR 211 maps out the operational building blocks of cGMP. Understand what you need for compliance, from lab to manufacturing line.

Jerry AdatsiApr 26, 2023
What you need to know about FDA 21 CFR Part 210
GxP

What you need to know about FDA 21 CFR Part 210

21 CFR 210 compliance is the first step to robust cGMP. Understand what your pharmaceutical or contract manufacturing organization needs in place.

Jerry AdatsiApr 21, 2023
Faster access to your quality landscape with our latest product upgrades
eQMS

Faster access to your quality landscape with our latest product upgrades

Our latest round of product updates focuses on giving our customers even faster, more intuitive access to their day-to-day quality data. Take a look what we did here.

Alex PavlovićApr 19, 2023
Ernie Wallerstein, Jr., CEO of Mental Health Technologies
Podcast

Ernie Wallerstein, Jr., CEO of Mental Health Technologies

How can technology be used to treat - and even model and predict - mental health? Ernie Wallerstein, CEO of Mental Health Technologies, thinks he has the answer.

Kelly StantonApr 18, 2023
Spring in our step at the G2 Spring Awards 2023
Company news

Spring in our step at the G2 Spring Awards 2023

We've kicked off 2023 with another haul of G2 awards! Big thanks to our wonderful customers and their reviews.

Alex PavlovićApr 14, 2023
Guide to GxP compliance: processes, challenges and tools
GxP

Guide to GxP compliance: processes, challenges and tools

GxP compliance isn’t optional for life science companies. Review GxP requirements, critical compliance tools and the key facts of GxP compliance.

Molly CalveyApr 14, 2023
Top pharmaceutical companies: 5 start-ups to watch in 2024
Pharmaceutical

Top pharmaceutical companies: 5 start-ups to watch in 2024

See our list of the top 5 most exciting pharmaceutical companies landing and expanding in 2023.

Lola FurlongApr 5, 2023
Enabling the next generation of biomarker discovery with Dr. Mo Jain, CEO of Sapient
Podcast

Enabling the next generation of biomarker discovery with Dr. Mo Jain, CEO of Sapient

The best lifesaving drugs only work 50% of the time. The reason? Broad-stroke treatments that gloss over the individual variations in our bodies. Dr. Mo Jain's Sapient wants to change all that.

Kelly StantonApr 5, 2023
What is cGMP in the pharma industry? 7 experts explain
Pharmaceutical

What is cGMP in the pharma industry? 7 experts explain

What is Current Good Manufacturing Practice (cGMP)? Why is it so important for pharma organizations? We interviewed 7 industry experts for the lowdown.

Meg SinclairMar 14, 2023
What is an ICH Q10 pharmaceutical quality system?
ICH

What is an ICH Q10 pharmaceutical quality system?

What is an ICH Q10 pharmaceutical quality system? It's your company's key to safe, effective and continuously improving products. Learn more with our breakdown guide.

Jerry AdatsiMar 7, 2023
ISO 13485 vs. ISO 9001: understanding the key differences for medical devices
Medical Devices

ISO 13485 vs. ISO 9001: understanding the key differences for medical devices

Discover the key differences in scope, significance and application between the ISO 13485 and ISO 9001 quality standards for medical devices.

Robert FentonFeb 24, 2023
5 notorious compliance issues in the pharmaceutical industry
Compliance

5 notorious compliance issues in the pharmaceutical industry

Ensure you don't receive an FDA 483 warning letter. Discover the most common compliance issues in the pharmaceutical industry and review your quality system.

Lola FurlongFeb 17, 2023
510(k) submission checklist to get your medical device to market
510(k)

510(k) submission checklist to get your medical device to market

A 510(k) submission checklist is a crucial tool for a controlled, confident and successful premarket notification. Get yours now!

Sumatha Kondabolu
Sumatha KondaboluJan 30, 2023
Qualio donates 1% of revenue to charity for a third consecutive year
Company news

Qualio donates 1% of revenue to charity for a third consecutive year

Qualio donates 1% of our annual revenue to improving healthcare access for vulnerable populations for the 2nd year in a row.

Robert FentonJan 19, 2023
5 tips for quality management compliance

5 tips for quality management compliance

Worried about your quality and compliance? We show you how to ensure your quality management system is tip-top, compliant and audit-ready.

Robert FentonJan 18, 2023
We just launched the best native document editor on the eQMS market
Document Control

We just launched the best native document editor on the eQMS market

Real-time collaboration, a new toolbar, fresh features and more! Our new editor is here to give our customers a true one-stop shop for their document management.

Alex PavlovićJan 18, 2023
Understanding the MDSAP's nonconformity grading system
Audit

Understanding the MDSAP's nonconformity grading system

The MDSAP program contains a unique 2-step system for grading audit nonconformities. Learn how it works with our breakdown.

Sumatha Kondabolu
Sumatha KondaboluJan 16, 2023
When to submit a 510(k) vs. a Premarket Approval
510(k)

When to submit a 510(k) vs. a Premarket Approval

File a 510(k) or apply for PMA? That is the question. Determining the best pathway to market for your medical device is key for success.

Alex PavlovićJan 12, 2023
The 6 most common triggers for FDA 21 CFR 820 non-compliance in 2022
Medical Devices

The 6 most common triggers for FDA 21 CFR 820 non-compliance in 2022

Where are US medical device companies going wrong with their 21 CFR 820 compliance? Form 483 inspectional observations reveal the most common non-conformance triggers.

Meg SinclairDec 22, 2022
Taking diagnostics to the future with Mehdi Maghsoodnia, CEO of 1Health
Podcast

Taking diagnostics to the future with Mehdi Maghsoodnia, CEO of 1Health

Today we’re talking to Mehdi Maghsoodnia, Co-founder of 1Health which is a personalized precision medicine powered by a lab testing platform that...

Kelly StantonDec 20, 2022
2023 is nearly here. Time to reflect on another successful year!

2023 is nearly here. Time to reflect on another successful year!

Company awards, product evolution, and a tenth birthday! As the year draws to an end, our CEO Rob Fenton looks back on a successful 2022 at Qualio.

Robert FentonDec 15, 2022
Qualio smashes customer review records at G2 Winter 2023 Awards
Industry Awards

Qualio smashes customer review records at G2 Winter 2023 Awards

We're ending the year in style, by winning more G2 awards than we've ever won before! Take a look at our haul here.

Alex PavlovićDec 14, 2022
Even faster and easier training with Training Plans
Product Updates

Even faster and easier training with Training Plans

We just made rapid organizational training at scale even easier for our customers with our brand new Training Plans functionality. Learn more here!

Alex PavlovićDec 12, 2022
510(k) exempt medical devices: how to tell if you need to submit
510(k)

510(k) exempt medical devices: how to tell if you need to submit

Unsure if your medical device is exempt from the FDA's 510(k) submission pathway? Here's a handy guide.

Alex PavlovićDec 12, 2022
Modernizing the Lab with Nathan Clark Cofounder of Ganymede
Podcast

Modernizing the Lab with Nathan Clark Cofounder of Ganymede

Nathan Clark of Ganymede talks about how the biotech lab of the future will look like on From Lab to Launch

Kelly StantonDec 9, 2022
The 5 best pharmaceutical consultants to work with in 2023
Pharmaceutical

The 5 best pharmaceutical consultants to work with in 2023

Need the help of a pharma or biotech expert in 2023? We've hunted down 5 consultants that should be on any shortlist.

Alex PavlovićNov 23, 2022
The 4 best ISO 13485 audit checklists
Medical Devices

The 4 best ISO 13485 audit checklists

These 4 free ISO 13485 audit checklists will help you achieve ISO 13485 compliance, prepare for certification and pass an audit.

Meg SinclairNov 18, 2022
The next wave of Qualio upgrades arrives
Product Updates

The next wave of Qualio upgrades arrives

We've been tinkering, tweaking and transforming! A fresh set of Qualio upgrades is ready to share with our customers. Dive in and see your new system.

Alex PavlovićNov 8, 2022
A step-by-step guide to internal quality audits
Compliance

A step-by-step guide to internal quality audits

An internal quality audit is important for measuring quality procedures. Learn the steps you should follow to make sure your internal audit is successful.

Jodi HutchinsOct 20, 2022
Qualio launches new validation approach
Computerized System Assurance

Qualio launches new validation approach

We've updated our validation approach to stay aligned with best practice and give our customers a faster, stress-free experience. Find out what we've changed!

Kelly StantonOct 19, 2022
Qualio takes prizes at the G2 Fall Awards 2022
Industry Awards

Qualio takes prizes at the G2 Fall Awards 2022

We just keep on winning accolades at G2's quarterly awards, thanks to stellar reviews from our customers! Here's how we did for Fall 2022.

Alex PavlovićSep 23, 2022
What are the types of quality audits?
Compliance

What are the types of quality audits?

There are several types of quality audits for life sciences companies. Learn about the different quality audit types and how to successfully prepare for them.

Jodi HutchinsSep 22, 2022
What is a bill of materials? A guide for medical devices
Medical Devices

What is a bill of materials? A guide for medical devices

A bill of materials is a list of components needed to manufacture your medical device. Learn why you need a BOM, how to create one and different BOM types.

Kelly StantonSep 15, 2022
The 10 key changes in the GAMP 5 Second Edition
Computerized System Assurance

The 10 key changes in the GAMP 5 Second Edition

The unveiling of the GAMP 5 Second Edition is part of the shift to a new world order of computer system adoption. Dive into the ten key changes here.

Alex PavlovićSep 13, 2022
Finding Root Causes of Conditions by Looking at Genetics with Dr. J Dunn
Podcast

Finding Root Causes of Conditions by Looking at Genetics with Dr. J Dunn

Ever wondered about your genes and overall health? In today's episode, we will talk about just that. with Dr. J Dunn. We go over wholistic kinesiology...

Kelly StantonSep 9, 2022
Everything you need to know about Design History Files (DHF)
Medical Devices

Everything you need to know about Design History Files (DHF)

Learn what a Design History File is and why it's important, the contents of a DHF, and how to prepare your DHF for an FDA Audit.

Meg SinclairSep 1, 2022
21 CFR Part 11: Compliance in the supply chain [Checklist]
Compliance

21 CFR Part 11: Compliance in the supply chain [Checklist]

Manufacturers must comply with 21 CFR Part 11, which includes documentation for supplier and logistics companies. Learn more and get our compliance checklist.

Kelly StantonAug 30, 2022
What you need to know about medical device validation
Medical Devices

What you need to know about medical device validation

Medical device validation determines whether you built the right product for its intended use. Learn the benefits and key steps of medical device validation.

Jodi HutchinsAug 23, 2022
How to start a pharmaceutical company
Pharmaceutical

How to start a pharmaceutical company

Find out what you need to start a pharma company. Learn how to get funding for your pharma startup, set up your quality management system and more.

Robert FentonAug 16, 2022
21 CFR Part 11: A guide for clinical trial compliance
Compliance

21 CFR Part 11: A guide for clinical trial compliance

Compliance with 21 CFR Part 11 is always required throughout the clinical trial process. Learn how sponsors, CROs and sites can comply with 21 CFR Part 11.

Kelly StantonAug 10, 2022
What is GxP in the life sciences industry?
GxP

What is GxP in the life sciences industry?

Explore the fundamentals of GxP in the modern life science environment and learn how to maintain compliance with GxP standards.

Meg SinclairAug 2, 2022
What is an electronic batch record?

What is an electronic batch record?

An electronic batch record is a system that substitutes the use of paper by digitizing said records. Find out the benefits of using electronic batch records and going paperless.

Kelly StantonAug 1, 2022
The pros & cons of pharmaceutical contract manufacturing
Pharmaceutical

The pros & cons of pharmaceutical contract manufacturing

Contract manufacturing organizations can be a great resource for pharmaceutical startups. Here are the pros and cons to consider before working with a CMO.

Lola FurlongJul 28, 2022
Medical device quality management system template: 8 powerful options
Medical Devices

Medical device quality management system template: 8 powerful options

With the right medical device quality management system template, you can quickly produce a market-leading device. Use these 8 templates to get started.

Meg SinclairJul 5, 2022
6 biotech incubators for startups in the U.S.
Biotech

6 biotech incubators for startups in the U.S.

Find a local biotech incubator to help your life science startup get off the ground. Here are 6 firms to consider for your early-stage biotech company.

Robert FentonJun 30, 2022
A comprehensive guide to ISO 14971: Risk management for medical devices
Medical Devices

A comprehensive guide to ISO 14971: Risk management for medical devices

Learn everything you need to know about ISO 14971, risk management for medical devices, and how to implement it into your quality management system.

Lola FurlongJun 28, 2022
Qualio maintains momentum at the G2 Summer Awards 2022
Industry Awards

Qualio maintains momentum at the G2 Summer Awards 2022

After a strong start to 2022, Qualio continued to generate the most momentum of any eQMS provider at the G2 Summer Awards. Find out how we did!

Alex PavlovićJun 27, 2022
The 5 best spots in the United States to start a life science company
Start-Up

The 5 best spots in the United States to start a life science company

Starting a business in a life science cluster offers easier recruitment, better funding and access to expertise and resources. Here's our list of the top 5 spots in the US.

Alex PavlovićJun 17, 2022
Biotech vs pharma: Differences and similarities
Pharmaceutical

Biotech vs pharma: Differences and similarities

Explore the differences in biotech vs. pharma companies when it comes to regulations and approvals. And learn how to start a pharma or biotech startup.

Kelly StantonJun 16, 2022
How to start a medical device company
Medical Device Start-Up

How to start a medical device company

Starting a successful medical device company is one of the most difficult enterprises you can embark on. Here's a detailed guide to help you on your way.

Alex PavlovićJun 13, 2022
A practical guide to implementing Risk Management for medical device startups
Medical Devices

A practical guide to implementing Risk Management for medical device startups

Follow this step-by-step approach to implementing risk management in your medical device startup and review what's essential in effective risk management.

Ezra KeldermanJun 9, 2022
5 ways to make the FDA audit process easier for your life sciences company
FDA

5 ways to make the FDA audit process easier for your life sciences company

FDA audits are a part of running a life sciences company. These 5 FDA audit preparation tips will improve your readiness and make things easier for your team.

Meg SinclairMay 27, 2022
Qualio launches triple integration release
Integrations

Qualio launches triple integration release

We're excited to add 3 fresh API integrations to our product offering. Find out more!

Alex PavlovićMay 19, 2022
How SaMD companies can use a QMS to improve regulatory compliance
Medical Devices

How SaMD companies can use a QMS to improve regulatory compliance

Without understanding regulatory expectations for software as a medical device (SaMD), an SaMD company may fail to meet FDA requirements. Learn how a QMS can help.

Ezra KeldermanMay 11, 2022
Qualio: officially Best Place To Work!
Culture

Qualio: officially Best Place To Work!

We're thrilled to announce that Qualio has been officially named in Inc. Magazine's Best Workplaces of 2022!

Robert FentonMay 10, 2022
The History and Innovation of CPR and EPR with Lyn Yaffe, CEO of EPR Technologies
Podcast

The History and Innovation of CPR and EPR with Lyn Yaffe, CEO of EPR Technologies

Lyn Yaffe, M.D., was instrumental to the development of the concept of EPR during the research and development work at the Safar Center of Resuscitation...

Kelly StantonMay 6, 2022
Tips for passing your MHRA inspection
MHRA

Tips for passing your MHRA inspection

Facing an MHRA inspection on your route to the UK market? Hear from the Qualio quality team - and one of our customers - about what you should do next.

Alex PavlovićApr 7, 2022
Empowering Women With Personal Fertility Knowledge with Dr. Amy Beckley of MFB Fertility
Podcast

Empowering Women With Personal Fertility Knowledge with Dr. Amy Beckley of MFB Fertility

Dr. Amy Beckley, founder and CEO of MFB Fertility and inventor of the Proov fertility test joins the show to talk about her journey as a scientist....

Robert FentonApr 6, 2022
Scaling insulin production with Cameron Owen, CEO/co-Founder of rBio
Podcast

Scaling insulin production with Cameron Owen, CEO/co-Founder of rBio

It's not hard to find someone who has been affected by diabetes and the rising cost of insulin. In fact, today's guest says that 1 in 10 people in the...

Grant HibbertMar 29, 2022
Qualio starts 2022 the right way at the G2 Spring Awards
Industry Awards

Qualio starts 2022 the right way at the G2 Spring Awards

Qualio claimed 1st position across the board in the Medical QMS category at the G2 Spring Awards 2022.

Alex PavlovićMar 23, 2022
Tips for moving from a paper-based QMS to an eQMS
eQMS

Tips for moving from a paper-based QMS to an eQMS

Make the switch from a paper-based quality management system to a digital eQMS. Follow these tips to make a painless transition from paper to digital.

Kelly StantonFeb 22, 2022
The quality manager's guide to rapid eQMS success: validation, adoption and implementation
eQMS

The quality manager's guide to rapid eQMS success: validation, adoption and implementation

More and more businesses are turning to an electronic quality management system (eQMS). But what does it mean to validate, implement and roll it out?

Alex PavlovićFeb 3, 2022
The 4 Best Medical Device Quality Assurance Training Options
Medical Devices

The 4 Best Medical Device Quality Assurance Training Options

Medical device quality assurance training can give your team the knowledge and confidence to move your company to the top of your industry.

Robert FentonJan 17, 2022
What Are The Essential Elements of Pharmaceutical Quality Management Systems? [8 Examples]
Pharmaceutical

What Are The Essential Elements of Pharmaceutical Quality Management Systems? [8 Examples]

Learn what makes the most effective Quality Management Systems (QMS) for pharmaceutical companies simplify complex cGMP and compliance requirements to drive TQM.

Molly CalveyJan 12, 2022
Qualio as a Force for Good: Year 2 of Improving Healthcare Access for Vulnerable Populations

Qualio as a Force for Good: Year 2 of Improving Healthcare Access for Vulnerable Populations

Qualio donates 1% of our annual revenue to improving healthcare access for vulnerable populations for the 2nd year in a row.

Robert FentonDec 22, 2021
4 Examples of Continuous Improvement in Quality Management in Life Sciences Companies
Quality Systems

4 Examples of Continuous Improvement in Quality Management in Life Sciences Companies

How do you foster continuous improvement in quality management for a life sciences company? Here are 4 examples of continuous improvement from which you can...

Robert FentonSep 9, 2021
What is a Device History Record (DHR)? [Definition and Components]
Medical Devices

What is a Device History Record (DHR)? [Definition and Components]

Learn what Device History Record is and how is it used?

Ezra KeldermanAug 31, 2021
The Risks of ISO 9001 Nonconformance
iso9001

The Risks of ISO 9001 Nonconformance

In this post, you'll learn how to identify the nonconformance discoveries that matter, common issues with ISO 9001:2015 standards and more.

Kelly StantonAug 24, 2021
What are the 6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations?
Medical Devices

What are the 6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations?

Wondering what's involved in producing a Clinical Evaluation Report for medical device organizations? Learn what the essentials are so you can accurately allocate resources to complete a medical device Clinical Evaluation Report.

Ezra KeldermanAug 19, 2021
What is the Device Master Record (DMR)?
Medical Devices

What is the Device Master Record (DMR)?

What is the Device Master Record and how is it used? We'll explain how to utilize DMRs for medical device safety and compliance...

Ezra KeldermanAug 17, 2021
How to respond to FDA warning letters
eQMS

How to respond to FDA warning letters

Have you received an FDA warning letter recently? There are a few crucial steps to follow when responding.

Alex PavlovićAug 12, 2021
3 FDA Design Control Requirements for Medical Device Startups
Medical Devices

3 FDA Design Control Requirements for Medical Device Startups

What are the most vital medical device design input requirements to be aware of? The FDA design control system can help your organization...

Ezra KeldermanAug 10, 2021
Rapidly Discovering and Extracting Natural Pharmaceuticals
Podcast

Rapidly Discovering and Extracting Natural Pharmaceuticals

Mental health issues have been on the minds of many as athletes are under tremendous pressure to perform perfectly at the Olympics.

Robert FentonAug 5, 2021
How Long Does the FDA Medical Device Approval Process Take? [Timeline]
Medical Devices

How Long Does the FDA Medical Device Approval Process Take? [Timeline]

Learn more about the FDA medical device approval process timeline and how you can ensure that your company won't run out of money before you start...

Robert FentonJul 27, 2021
Identifying the 4 Most Common Problems With Your CAPA Process
eQMS

Identifying the 4 Most Common Problems With Your CAPA Process

What are the most common problems that occur within CAPA processes? Learn how to identify issues before they start and how to avoid them...

Kelly StantonJul 22, 2021
5 Major Total Quality Management Principles for Medical Device Startups
eQMS

5 Major Total Quality Management Principles for Medical Device Startups

What are the most vital total quality management principles for medical device startups to follow? Learn how successful new medical startups...

Kelly StantonJul 20, 2021
Regulatory Expectations for Software as a Medical Device (SaMD) Startups
Medical Devices

Regulatory Expectations for Software as a Medical Device (SaMD) Startups

What are the regulatory expectations for software as a medical device (SaMD) startup companies? Learn which requirements SaMD companies...

Kelly StantonJul 15, 2021
What's the Difference Between Biopharmaceutical vs. Pharmaceutical Startups?
Pharmaceutical

What's the Difference Between Biopharmaceutical vs. Pharmaceutical Startups?

What are the key differences between biopharmaceutical and pharmaceutical startups? Biopharma and traditional pharma startups both share...

Kelly StantonJul 8, 2021
How to Get IEC 60601-1 Approval in 5 Easy Steps
Medical Devices

How to Get IEC 60601-1 Approval in 5 Easy Steps

Use our guide to obtain IEC 60601-1 approval for your medical device by controlling for safety and performance requirements in 5 easy steps...

Ezra KeldermanJul 6, 2021
Qualio now offers industry-leading high availability
Updates

Qualio now offers industry-leading high availability

We made Qualio a high available product to help life science companies bring products to market faster.

Louis SuchyJun 29, 2021
Launching the First Single-use Endoscope for Unsedated Pediatric Endoscopy with Dr. Heather Underwood, CEO of EvoEndo
Podcast

Launching the First Single-use Endoscope for Unsedated Pediatric Endoscopy with Dr. Heather Underwood, CEO of EvoEndo

Today’s guest on the podcast is Dr. Heather Underwood, CEO of EvoEndo. She talks about launching the first unsedated single-use endoscope to market.

Robert FentonJun 16, 2021
3 Important FDA Medical Device Guidance Documents to Bookmark
Medical Devices

3 Important FDA Medical Device Guidance Documents to Bookmark

What are the most important medical device guidance documents that your life science organization should bookmark? Start by...

Kelly StantonJun 3, 2021
Announcing Qualio's $50M Series B Funding Round
Updates

Announcing Qualio's $50M Series B Funding Round

Today, we get to celebrate another milestone. Qualio has raised a $50M Series B led by Tiger Global. Learn more about...

Robert FentonMay 25, 2021
The Top 3 Pharmaceutical Venture Capital Firms
Pharmaceutical

The Top 3 Pharmaceutical Venture Capital Firms

Are you in investment banking for the pharmaceuticals industry? Here are the top companies to watch, including...

Kelly StantonMay 20, 2021
EU Medical Device Training: 4 Amazing Programs
Medical Devices

EU Medical Device Training: 4 Amazing Programs

What are the top EU medical device training programs this year? To start, we recommend...

Ezra KeldermanMay 18, 2021
What is the ISO 13485 Quality Manual?
ISO 13485

What is the ISO 13485 Quality Manual?

An ISO 13485 Quality Manual is critical for medical device manufacturers to prove compliance with...

Kelly StantonMay 13, 2021
Biopharma Quality Management: 5 Steps to Guarantee Regulatory Compliance
Pharmaceutical

Biopharma Quality Management: 5 Steps to Guarantee Regulatory Compliance

Proper biopharma quality management can guarantee regulatory compliance. Follow these 5 steps to...

Kelly StantonMay 11, 2021
4 Major Class II Medical Device Requirements
Medical Devices

4 Major Class II Medical Device Requirements

Looking for Class II medical device requirements? We've compiled the largest requirements that send many teams back to the drawing board...

Kelly StantonMay 6, 2021
What is the FDA 21 CFR? Requirements Overview
FDA

What is the FDA 21 CFR? Requirements Overview

Need information on FDA 21 CFR? Simply put, the Code of Federal Regulations, Title 21 is...

Kelly StantonMay 6, 2021
How to Prepare for and Pass an Audit – and What to Do Next
Compliance

How to Prepare for and Pass an Audit – and What to Do Next

What is the best way to prepare for and pass an audit? Qualio's Direct of Quality Kelly Stanton recently hosted a customer panel featuring...

Teena HartMay 4, 2021
How to Build a Document Control Procedures Manual
eQMS

How to Build a Document Control Procedures Manual

Is your life sciences organization struggling with document control? Learn how to build a document control procedures manual to...

Kelly StantonApr 29, 2021
How to Master Pharmaceutical QA in 4 Simple Steps
Pharmaceutical

How to Master Pharmaceutical QA in 4 Simple Steps

Are you struggling with pharmaceutical QA? Follow these simple steps to master pharmaceutical QA and...

Kelly StantonApr 6, 2021
Qualio Ranks #1 in QMS Usability, Implementation, and Satisfaction on G2
Updates

Qualio Ranks #1 in QMS Usability, Implementation, and Satisfaction on G2

Qualio named #1 in usability and implementation for QMS in G2's 2021 Spring Report.

Teena HartMar 23, 2021
How to Get Non-Dilutive Funding via Federal Agencies
Podcast

How to Get Non-Dilutive Funding via Federal Agencies

Over $50B (with a B!) is available each year to life science companies from federal agencies. The best part is, it's all non-dilutive funding.

Robert FentonMar 17, 2021
What are the best pharmaceutical quality assurance courses online?
Pharmaceutical

What are the best pharmaceutical quality assurance courses online?

Learn about the best pharmaceutical quality assurance courses online and how continuing education is important for quality assurance and quality control professionals in pharmaceuticals.

Robert FentonMar 9, 2021
How A Document Control System Can Transform Your Business [7 Benefits]
Document Control

How A Document Control System Can Transform Your Business [7 Benefits]

Learn what a document control system is, how it can transform your business, which benefits it offers, and what features to look for.

Robert FentonMar 4, 2021
How to maintain and improve quality management while working remotely
Podcast

How to maintain and improve quality management while working remotely

Today, we're introducing a new type of episode called quality quick tips.

Grant HibbertMar 3, 2021
Qualio is Officially ISO 9001 Certified!
Updates

Qualio is Officially ISO 9001 Certified!

Qualio is officially ISO 9001 Certified.

Kelly StantonFeb 1, 2021
Understanding CAPA for medical devices: key concepts and requirements
Medical Devices

Understanding CAPA for medical devices: key concepts and requirements

Learn about CAPA for medical devices, explore examples, and understand the implementation process to ensure compliance and safety.

Sumatha Kondabolu
Sumatha KondaboluJan 14, 2021
5 Essential Elements of Quality Management Software
eQMS

5 Essential Elements of Quality Management Software

Not all quality management software is created equal. These are the five essential elements that...

Robert FentonDec 22, 2020
Improving Healthcare Access for Vulnerable Populations
Updates

Improving Healthcare Access for Vulnerable Populations

Starting this year, Qualio will donate 1% of our annual revenue to improving healthcare access for vulnerable populations.

Robert FentonDec 22, 2020
From Hippie to Med School to Entrepreneur with Dr. Hana, MD
Podcast

From Hippie to Med School to Entrepreneur with Dr. Hana, MD

Dr. Hana Solomon, MD shares her journey from hippie to single-mother to med school to entrepreneur. She's the founder of BeWell Health and inventor of Nasopure, the most comfortable nose wash in the world. She shares her wisdom to avoid "stupid business mistakes" such as acquiring the right type of

Robert FentonDec 16, 2020
Does an FDA Class 1 Medical Device List Exist?
Compliance

Does an FDA Class 1 Medical Device List Exist?

Learn about the pathway to approval if your product can be classified as a Class 1 medical device.

Robert FentonNov 10, 2020
What Are the Objectives [5 Examples] of Quality Assurance in the Pharmaceutical Industry?
Quality Systems

What Are the Objectives [5 Examples] of Quality Assurance in the Pharmaceutical Industry?

Learn about the 5 critical objectives of quality assurance in the pharmaceutical industry. If you don't want to fall behind the competition, you need to ensure...

Robert FentonOct 20, 2020
FDA to Issue New Guidance on QMS Validation: 4 Major Changes
FDA

FDA to Issue New Guidance on QMS Validation: 4 Major Changes

The FDA plans to issue new guidance on QMS validation. Here are some of the changes that we...

Robert FentonOct 15, 2020
5 Major IEC 62304 Compliance Mistakes Medical Software Manufacturers Make
Compliance

5 Major IEC 62304 Compliance Mistakes Medical Software Manufacturers Make

IEC 63204 compliance is a functional safety standard that applies to medical device development and maintenance. We've found that most...

Robert FentonOct 13, 2020
The ISO 13485 Checklist for Medical Device Manufacturers
ISO 13485

The ISO 13485 Checklist for Medical Device Manufacturers

Are you preparing for ISO 13485 certification? Consult this helpful ISO 13485 checklist so that you can streamline certification and...

Robert FentonOct 8, 2020
Understanding Risk Classification of Medical Devices: 3 Major Grades
Medical Devices

Understanding Risk Classification of Medical Devices: 3 Major Grades

The FDA CDRH risk classification is based on the risk associated with your medical device. There are three risk classifications of medical devices including...

Robert FentonSep 24, 2020
The 5 Best Medical Device Product Lifecycle Management Tools
Medical Devices

The 5 Best Medical Device Product Lifecycle Management Tools

Let's look at the best medical device product lifecycle management (PLM) options to determine which will help you avoid big problems and...

Robert FentonSep 10, 2020
What is eQMS Software Validation?
eQMS

What is eQMS Software Validation?

In the medical device industry, eQMS software validation is a required step in the onboarding process. You might not know that when...

Robert FentonSep 3, 2020
What Are The Top FDA Software Validation Requirements? [Review]
FDA

What Are The Top FDA Software Validation Requirements? [Review]

Learn about the FDA and its current guidance on General Principles of Software Validation and how it has changed since its initial release date in 2002.

Robert FentonSep 1, 2020
Top 7 Biotech Investors Changing the Life Science Industry
Business

Top 7 Biotech Investors Changing the Life Science Industry

Is your biotech company trying to raise a new funding round? These amazing biotech investors have...

Robert FentonAug 27, 2020
5 Essential Elements of a QMS for Medical Devices
Medical Devices

5 Essential Elements of a QMS for Medical Devices

Finding the right QMS system for medical devices can be a challenge. You need to prioritize these core elements including...

Robert FentonAug 25, 2020
4 FDA Medical Device Reporting Procedures for Life Science Companies
Medical Devices

4 FDA Medical Device Reporting Procedures for Life Science Companies

What are the FDA medical device reporting procedures that you need to know about. The following...

Robert FentonAug 11, 2020
What's the difference between a Class I and Class II medical device?
Medical Device Classification

What's the difference between a Class I and Class II medical device?

Learn the difference between a Class I and Class II Medical Device. It's a question that we get all the time and...

Jerry AdatsiJul 28, 2020
An ISO 13485 Risk Management Plan Example You Can Steal and Use
Medical Device Risk Management

An ISO 13485 Risk Management Plan Example You Can Steal and Use

There are times when creativity is a good thing, but putting together an ISO 13485 risk management plan isn't one of them.

Robert FentonJul 21, 2020
How to Get a Quality Management Certification in 5 Simple Steps
Certification

How to Get a Quality Management Certification in 5 Simple Steps

Getting a quality management certification can feel overwhelming. Follow these simple steps to...

Robert FentonJul 2, 2020
5 Essential Tasks to Include in Your EU MDR Checklist
Medical Devices

5 Essential Tasks to Include in Your EU MDR Checklist

As you prepare for EU MDR, what are the tasks that you should absolutely include in your readiness checklist? We've found...

Robert FentonJun 30, 2020
The 5 Best ISO 14971 Training Programs
Medical Devices

The 5 Best ISO 14971 Training Programs

ISO 14971 is an ISO standard for the application of risk management for medical devices. Here are the best ISO 14971 training programs to...

Robert FentonJun 25, 2020
5 Online Medical Device Design Control Templates
Medical Devices

5 Online Medical Device Design Control Templates

Don't let design controls trip you up. Pick one of these five medical device design control templates to speed up your design process and ensure...

Robert FentonJun 18, 2020
FDA Regulatory Compliance Software?: Cloud vs. On-Premises [Explained]
Paper-Based

FDA Regulatory Compliance Software?: Cloud vs. On-Premises [Explained]

Should you use a cloud-based FDA regulatory compliance software or host your solution on-premise?

Ezra KeldermanMay 15, 2020
5 Pharmaceutical Manufacturing and Quality Management Trends
eQMS

5 Pharmaceutical Manufacturing and Quality Management Trends

Is your pharmaceutical manufacturing company struggling to stay ahead of the curve?

Robert FentonMay 14, 2020
What Are The 4 Phases of Clinical Trials? (And How to Guarantee Quality Assurance During Every Step)
Pharmaceutical

What Are The 4 Phases of Clinical Trials? (And How to Guarantee Quality Assurance During Every Step)

Learn about the 4 phases of clinical trials and what mistakes many life science companies make..

Kelly StantonMay 7, 2020
How to Set Up an ISO 14971 Risk Matrix in 5 Simple Steps
eQMS

How to Set Up an ISO 14971 Risk Matrix in 5 Simple Steps

We'll show you how to set up your own ISO 14971 risk matrix in just a few steps to give your company confidence and consistency and keep your organization...

Robert FentonApr 15, 2020
6 Best Practices from Six Sigma that Medical Device Companies Should Follow
Medical Devices

6 Best Practices from Six Sigma that Medical Device Companies Should Follow

Ready to make your medical device business better? Check out the six best practices of Six Sigma medical device companies that you should implement to get

Robert FentonMar 12, 2020
Design Controls for a Medical Device: 5 Secrets for Success
Medical Devices

Design Controls for a Medical Device: 5 Secrets for Success

Need expert advice on design controls for a medical device? With these five secrets, you'll be able to document insights that lead to profitable...

Robert FentonMar 3, 2020
7 ISO 13485:2016 Changes That Can Make Your Company Better
ISO 13485

7 ISO 13485:2016 Changes That Can Make Your Company Better

Has your medical device company lost its competitive edge? We've identified seven specific ISO 13485:2016 changes and how you can...

Robert FentonFeb 27, 2020
Medical Device Consultant Rates for 2020: What You Should Get for Your Investment
Medical Devices

Medical Device Consultant Rates for 2020: What You Should Get for Your Investment

Medical device consultant rates fluctuate along with changes in the medical field. There are 5 things to know about consultant rates so you don't risk ...

Robert FentonFeb 11, 2020
Reviewing the Best Medical Device Risk Management Consultant Options for 2020
Medical Devices

Reviewing the Best Medical Device Risk Management Consultant Options for 2020

A medical device risk management consultant can help reduce your anxiety and ensure that every single one of the products that leave your facility will...

Robert FentonJan 30, 2020
How to find the best pharmaceutical regulatory consulting services
Pharmaceutical

How to find the best pharmaceutical regulatory consulting services

This is your essential guide to finding the best pharmaceutical regulatory consulting services for your pharma company.

Lola FurlongJan 28, 2020
Medical Device Compliance Consulting: 11 Questions to Ask Before Hiring
Compliance

Medical Device Compliance Consulting: 11 Questions to Ask Before Hiring

Working with a great medical device compliance consulting firm could keep you on the good side of regulatory bodies & ensure that your organization does not...

Robert FentonJan 7, 2020
How Much Does Medical Device Regulatory Consulting Cost in 2020?
Medical Devices

How Much Does Medical Device Regulatory Consulting Cost in 2020?

How much do medical device regulatory consulting firms charge? That's the first question to ask when trying to...

Robert FentonDec 24, 2019
5 Staggering Medical Device Recall Statistics That Should Concern Everyone
Medical Devices

5 Staggering Medical Device Recall Statistics That Should Concern Everyone

Faulty medical devices can have catastrophic consequences! These alarming medical device recall statistics should cause you to lose sleep—unless you have...

Robert FentonDec 10, 2019
6 Signs Your Quality Management Process Is Failing
Quality Systems

6 Signs Your Quality Management Process Is Failing

Is your company vulnerable to recalls, reputational damage, and regulatory issues because of quality management process problems? We'll show you five...

Robert FentonNov 27, 2019
5 Common Medical Device Regulatory Compliance Problems Faced in 2020
Medical Devices

5 Common Medical Device Regulatory Compliance Problems Faced in 2020

These 5 medical device regulatory compliance problems can kill life sciences companies. If you're making these errors, make an adjustment now, before you...

Robert FentonNov 19, 2019
The Top 4 ISO 13485 Gap Analysis Templates: Pros and Cons
ISO 13485

The Top 4 ISO 13485 Gap Analysis Templates: Pros and Cons

We've reviewed the best ISO 13485 gap analysis templates to help you pick the right one so that you can close the gaps and make substantial...

Robert FentonNov 14, 2019
The Quality Policy of Pharmaceutical Industry Leaders Includes These 5 Things
Quality Systems

The Quality Policy of Pharmaceutical Industry Leaders Includes These 5 Things

The quality policies of pharmaceutical industry leaders are clear, simple, and distributed widely. By learning from them, you can ensure that your team...

Robert FentonNov 12, 2019
How to Shrink the FDA Medical Device Approval Timeline
Medical Devices

How to Shrink the FDA Medical Device Approval Timeline

What kind of difference would it make if you could shave 30 days off the FDA medical device approval timeline? For some companies, it could mean...

Robert FentonNov 7, 2019
How to Pass Every Quality Management Audit Without Breaking a Sweat
Quality Systems

How to Pass Every Quality Management Audit Without Breaking a Sweat

Don't let a quality management audit scare you to death. Implementing these 7 preparations will position you to pass the next audit without any of the...

Robert FentonOct 31, 2019
How to Solve 5 Common Document Control Procedure Problems
eQMS

How to Solve 5 Common Document Control Procedure Problems

Is document control giving you a migraine? Let's look at the most common document control procedure problems and how to avoid them so that your team can...

Robert FentonOct 24, 2019
Preclinical Testing of Medical Devices: 7 Essential Steps to Prepare
Medical Devices

Preclinical Testing of Medical Devices: 7 Essential Steps to Prepare

By preparing well for preclinical testing of medical devices, you'll pass this important step with flying colors, impressing 3rd-party reviewers and securing...

Robert FentonOct 17, 2019
5 Medical Device Compliance Problems That Can Permanently Damage Life Sciences Companies
Compliance

5 Medical Device Compliance Problems That Can Permanently Damage Life Sciences Companies

By dodging some of the most common medical device compliance problems, you can not only ensure you pass the regulations, but safeguard your company from...

Robert FentonOct 15, 2019
The 4 Worst Supplier Quality Management Procedure Problems for Life Sciences Organizations
Quality Systems

The 4 Worst Supplier Quality Management Procedure Problems for Life Sciences Organizations

Supplier quality management procedure problems can sink your company in a hurry. Ignorance of these issues is dangerous. We've put together this list so you...

Robert FentonSep 26, 2019
The 6 Best Medical Device Regulatory Consulting Services in 2020
Medical Devices

The 6 Best Medical Device Regulatory Consulting Services in 2020

Looking for the best medical device regulatory consulting services? These 6 consultancy firms have the experience to help you solve difficult challenges with...

Robert FentonSep 12, 2019
9 Helpful Document Control Tips You Can Implement Right Now
eQMS

9 Helpful Document Control Tips You Can Implement Right Now

Here are 9 document control tips guaranteed to make quality management in your company better. Implement these best practices and you'll get ...

Robert FentonSep 5, 2019
ISO Compliance: The What, Why, and How for Life Sciences Companies
Compliance

ISO Compliance: The What, Why, and How for Life Sciences Companies

What is ISO compliance? Click through to learn what it is, why it exists, and how to make it benefit your company without ever losing a....

Robert FentonAug 27, 2019
9 Ways Canadian Medical Device Regulations Differ From the US
Medical Devices

9 Ways Canadian Medical Device Regulations Differ From the US

Considering expanding your medical device sales to Canada? Is passing Canadian regulations going to be too big of a pain to make it worth it?

Robert FentonJul 30, 2019
What's the Best Corrective Action Database Software?
Paper-Based

What's the Best Corrective Action Database Software?

Do you view corrective action systems as a necessary evil or an opportunity to become the best?

Robert FentonJul 23, 2019
Product Realization ISO 13485 In Layman's Terms
ISO 13485

Product Realization ISO 13485 In Layman's Terms

What are the salient points of the ISO 13485 product realization guidelines?

Robert FentonJul 18, 2019
4 Regulations That Apply to Medical Device CRO Selection
Medical Devices

4 Regulations That Apply to Medical Device CRO Selection

How can you make sure that you're selecting the right contract research organization (CRO) for your medical device?

Robert FentonJul 16, 2019
The Pros and Cons of Medical Device Consulting
Medical Devices

The Pros and Cons of Medical Device Consulting

Will using medical device consulting services be a net positive for your business, or would you be better off spending the money elsewhere?

Robert FentonJul 11, 2019
The EU Med Device Regulation Timeline: What You Should Know in 2020
Medical Devices

The EU Med Device Regulation Timeline: What You Should Know in 2020

The EU has designated a transition period from the decades-old Medical Device Directive to the new Medical Device Regulation which ends in May of 2020.

Robert FentonJun 27, 2019
Evaluating Contract Sales Organizations for Medical Device Companies
Medical Devices

Evaluating Contract Sales Organizations for Medical Device Companies

If your medical device company has hit a sales slump, a contract sales organization can be the solution to get you back on track.

Robert FentonJun 25, 2019
Which Conformity Assessment Should Med Device Companies Choose
Medical Devices

Which Conformity Assessment Should Med Device Companies Choose

Choosing the right conformity assessment for your medical device company will ensure you get approval without wasting resources.

Robert FentonJun 20, 2019
Who’s the Best FDA Consultant for Medical Device Manufacturers?
Medical Devices

Who’s the Best FDA Consultant for Medical Device Manufacturers?

Worried that passing FDA regulations for your medical device is going to slow time-to-market and cause your team massive headaches?

Robert FentonJun 4, 2019
The Essential Parts of an ISO 13485 Medical Device QMS
ISO 13485

The Essential Parts of an ISO 13485 Medical Device QMS

Using a QMS specifically designed for ISO 13485 is a smart move, but how do you know when you've found a good one? Look for features like ...

Robert FentonMay 28, 2019
Quality vs. Compliance: These 5 Questions Will Determine Your Focus
Compliance

Quality vs. Compliance: These 5 Questions Will Determine Your Focus

Learn about the main differences between Quality vs. compliance. They're both necessary components to product development, but as an organization, it's critical to understand the differences.

Robert FentonApr 9, 2019
What Are The 4 Reasons You Need An Agile QMS? (And The Easiest Way to Get One)
eQMS

What Are The 4 Reasons You Need An Agile QMS? (And The Easiest Way to Get One)

Learn how an effective eQMS provides the right balance of structure and flexibility to achieve organizational agility.

Robert FentonMar 28, 2019
What An ISO 13485 Quality Manual For Medical Devices Should Look Like
ISO 13485

What An ISO 13485 Quality Manual For Medical Devices Should Look Like

The quality manual for medical devices is a document required by ISO 13485, a quality management system designed for medical device manufacturers.

Robert FentonMar 26, 2019
The Top 5 Cloud-Based Quality Management System Options for 2020
Paper-Based

The Top 5 Cloud-Based Quality Management System Options for 2020

It's important to compare a few eQMS options, as every company that requires a cloud-based QMS is different, with varying expectations and needs.

Robert FentonFeb 14, 2019
How to Achieve Effective Quality Assurance
Pharmaceutical

How to Achieve Effective Quality Assurance

An effective QMS can create clarity in a difficult circumstance, while a needlessly over-engineered QMS can damage project results.

Robert FentonJan 29, 2019
Essential Tools to Achieve Compliance in the Pharmaceutical Industry
Pharmaceutical

Essential Tools to Achieve Compliance in the Pharmaceutical Industry

What are the essential tools you need for regulatory compliance in the pharmaceutical industry?

Robert FentonDec 18, 2018
13 Bottom Line-Boosting Benefits of a Quality Management System
eQMS

13 Bottom Line-Boosting Benefits of a Quality Management System

Quality management system (QMS) software isn't an expense, it's an asset to life science companies.

Robert FentonNov 29, 2018
How to Evaluate and Choose the Best Consultant
Quality-Driven

How to Evaluate and Choose the Best Consultant

When evaluating quality management consultants, look for relevant industry experience, proof of successfully designed management systems, relevant QMS ...

Robert FentonNov 27, 2018
QMS Software: 7 Features That Save You Time, Money, and Resources
Paper-Based

QMS Software: 7 Features That Save You Time, Money, and Resources

Life science companies should look for QMS software which provides real-time web-based collaboration features and automated quality management workflows.

Robert FentonNov 15, 2018
5 Ways that a QMS Improves ISO 9001 Management
iso9001

5 Ways that a QMS Improves ISO 9001 Management

Learn how Qualio's QMS can help you use ISO 9001 principles to adhere to guidelines and bring your life sciences product to market faster.

Pat FlandersSep 28, 2016
Qualio Among Fastest Growing Irish Companies
Ireland

Qualio Among Fastest Growing Irish Companies

Qualio was recently identified as one of Ireland's fastest-growing companies. Their product innovation and global expansion were among the noted achievements.

Pat FlandersSep 12, 2016
If it’s not documented, it didn’t happen
eQMS

If it’s not documented, it didn’t happen

Guide to improving document control in line with FDA Good Documentation Practice

Nancy WattsNov 18, 2014
Failure to Comply - Document Control in a Regulated Industry
Document Control

Failure to Comply - Document Control in a Regulated Industry

It is not possible to understate the importance of effective document control in a highly-regulated industry such as medical devices. Effective...

Dr. Christopher DevineApr 28, 2014