AI-enabled device makers can't move at the pace their technology allows when compliance is only checked point-in-time. Qualio assesses compliance continuously, eliminating the pause-and-resubmit cycle.
Dev & Quality, Together
Increase product development velocity
With Qualio, development and compliance happen in parallel. Understand when compliance requirements impact design in real-time.
Trusted by 300+ medical device leaders
The Solution
Compliance that moves at the speed of product development
2x speed to market with unified product lifecycle management
Qualio connects directly with Jira, Azure DevOps, GitHub, and TestRail, so design history and objective evidence build automatically as your team works.
Move faster with cybersecurity threat & regulatory monitoring
Beacons monitor your ecosystem and external threat feeds for changes that affect your ISO 27001, FDA, and GxP compliance.
Get audit-ready faster
Built-in ISO 13485, QMSR, MDR, and MDSAP compliance.
The Results
80%
faster audit readiness, Sentec
2x
faster speed to market, InVivo Bionics
$130k
cost savings, NeuFit
Regulated product life cycle management
- Instantly identify gaps with full traceability from requirements to user needs to design inputs, outputs, tests, and risks
- Automate design review and release documentation generation, from risk assessments to user requirements and Change History Reports
- Monitor regulatory compliance and close gaps as you build
Powerful dev tool integrations
- Pull design elements from Jira, TestRail, XRay, Zephyr Cloud, Linear, Azure DevOps, GitHub, and GitLab and more straight into Qualio
- Automate objective evidence collection from external systems within Qualio to speed audit-readiness
- Qualio monitors your development data for compliance risks and guides resolution
Qualio AI Copilot & MCP server
- Compliance context and guidance for non-experts at your fingertips
- Close compliance gaps and make code changes that keep you compliant, in your own tools
Don't just take our word for it!
Hear from our happy medical device QMS software customers
“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
“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
“Qualio is a superb eQMS solution for medical devices.”
Andrew R.
Director of Tech & Quality, Medbaye
“The validation documentation provided by Qualio was easy to understand and execute.”
Soni M.
QA/RA Director, NovoSource
