AI Agents and Co-pilot

Continuous analysis and guidance to keep you audit-ready at a fraction of the cost and effort.

Qualio's agentic layer monitors every framework you operate under. It remediates continuously without waiting to be asked. The platform handles the manual work, all you have to do is review and approve.

See the Agentic Platform Book a Demo

Trusted by life sciences teams who can't afford compliance gaps

The problem with the status quo

Manual, reactive compliance is expensive, slow and increasingly ineffective.

Traditional workflows are no longer suitable for the AI-driven reality of Life Sciences. Throwing people at the problem and chasing data from scattered systems is becoming a liability. Compliance teams need new tools to manage risk efficiently and effectively.

< 1hr

Scan a full quality system in under an hour.

< 5min

Go From detected gap to remediated document in under 5 minutes

Handle more audits per year without adding headcount or consultant spend

How it works

Continuous compliance automates the heavy lifting, keeping you in control and audit-ready.

Run gap analysis against every active framework on your entire QMS in less than an hour. Qualio detects gaps and suggests remedies keeping you ahead of audits without increasing spend.

No more downloading and uploading of documents to leverage AI. AI Copilot is an on-demand interactive assistant with full context of your compliance state that delivers traceable and consistent results you can’t get from manual prompting of AI.

Continuously monitor the world to catch signals like FDA warning letters, ISO standard updates and security advisories. Beacons score everything against your specific context helping your team stay compliant without adding headcount.

Use your quality data in the AI tools your team already works in.

Qualio's MCP Server connects your QMS to tools like Claude and ChatGPT so that you can use AI to prompt the data in your QMS without ever leaving the tools your team works with.

What quality and regulatory teams say

"We selected Qualio based on functionality and ease of transition. We now leverage Qualio across our entire organization."

Holly Rundle

Director of Compliance, StayinFront

"Qualio simplified things immensely."

Andrew Breite

Director of Quality Assurance, VitaCyte

"We're so streamlined now. It's amazing where we were, compared to where we are now. I hope we get the same auditor in future, so I can say, look how wonderful this is now."

Ami Anderson

Director of Operations & Quality Management, NeuFit

"We now have a consolidated device file which reflects the development of our product. 18 months ago, we didn't have anything like that."

Phil Cooley

Quality Manager, Bond Digital Health

"Me getting back hundreds of hours in a year thanks to Qualio is the equivalent of about one FTE."

Mike Trudnak

VP of IT & Information Security, xCures

"The validation documentation provided by Qualio was easy to understand and execute."

Soni M.

QA/RA Director, NovoSource

"My favourite thing is how Qualio keeps us in a constant state of audit readiness."

Deb G.

Director of Quality, Dimension Therapeutics

"Just building a compendium of everything you need to show the notified bodies can be tricky if you're doing it manually. We wanted to start on the right footing."

Daniel Aragao

CTO, InVivo Bionics

"I found that Qualio was meeting the company's needs without needing to be customized too deeply."

Peter Bruesehoff

Director of Quality Assurance, Watchmaker Genomics

"CI surfaces gaps automatically. We resolve issues faster and walk into audits with confidence."

Christophe Dohr

Site Quality Manager, Sentec

"I contacted Qualio in November. We went live mid-December. We had all users in by January. And we had our ISO 13485 certification in July. Without Qualio, we'd never have done that."

Karen H.

Head of Quality & GxP Compliance, 30 Technology

"We passed our MDSAP recertification audit with Qualio!"

John P.

Quality Assurance Manager, KUBTEC Medical Imaging

"A digital trail is so important in medical devices... two years from now when you're looking back, you will find it."

Andrew L.

CEO, ArcScan

"We needed something that was user-friendly, easy to onboard new team members, and easy to get up and running. Qualio has surpassed our expectations on those metrics."

Stephana P.

VP of Quality, Alphazyme

"The primary benefit of Qualio came with the newfound ease of passing internal and external audits."

Tyler Cochran

Executive Director of Quality, Linical Americas, Linical

"With other eQMS systems, I almost felt like I should've taken classes in coding. They were so convoluted and confusing — and making procedures to train other people how to use them was also difficult."

Angela Pinkston

QA Manager, Akadeum Life Sciences

"Qualio gives everyone a roadmap in this time when we're having to move very quickly. Having that structure for everyone to work within is going to be essential for us to really succeed."

Heather Underwood

CEO, EvoEndo

"We can now offer instant access to a library of 325 controlled documents, confident in the system's availability and ease of use."

Quality Team

(no named individual in public materials), eClinical Solutions

"Qualio is a superb eQMS solution for medical devices."

Andrew R.

Director of Tech & Quality, Medbaye

"With other vendors, we felt like just a number. But this is like a true partnership. Qualio has definitely changed our world."

Eric D.

Director of Quality Assurance, Expression Therapeutics

A compliance posture you can verify at any time, not just before an audit.

Qualio's agentic layer handles the monitoring, the gap analysis, and the groundwork, continuously, so your team's attention stays on decisions that actually require it.

See the Agentic Layer in action Book a Demo