Qualio | AI Compliance Platform for Life Sciences
The Agentic Compliance Platform for Life Sciences
AI-powered compliance for life sciences, medical devices, SaMD, GxP Software, pharma, and biotech. AI-powered compliance for medical devices
Accelerate product development with an AI-powered quality and compliance platform. AI agents run gap analyses, monitor regulatory changes, and execute workflows to stay audit-ready and bring products to market faster.
Compliance Intelligence
Last updated: Today
Live
87% Compliance score
3 Critical gaps
24 Controls mapped
| Requirement | Status | Action |
|---|---|---|
| Design Controls | Compliant | View evidence |
| Risk Management | In Progress | Remediate → |
| CAPA Process | Gap Found | Remediate → |
| Document Control | Compliant | View evidence |
CI Agent: Completed QMSR gap analysis 4 new controls mapped
FROM 20+ WEEKS TO <4 FOR AUDIT READINESS
Compliance Intelligence
Automate gap analysis across FDA, ISO and EMA standards, along with 28 others. Cross-map evidence once, reuse across submissions. Get real-time risk alerts and board-ready dashboards, so you can expand into new markets with confidence. Proven Results: 80% reduction in audit prep time | 5x ROI in 2 months | 60% lower consultant spend
How the modern compliance platform works
The bar has never been higher for life science companies.
Every fresh regulation, new product you launch or new market you target adds to a complex web of regulatory demands.
Qualio unites quality management, product lifecycle and compliance intelligence in a single, integrated platform. With AI-powered gap analysis, cross-mapped evidence and continuous monitoring, we get you audit-ready in weeks instead of months — so you can launch faster, protect revenue and scale globally with confidence.
Trusted by 700+ highly regulated customers across the globe
Constant audit readiness in a world of changing regulations
Our customers use our software to comply with:
Purpose-built for life science companies
Qualio serves the entire life science ecosystem. Find out how we support your specific industry.
Medical Devices
Streamline a fast, safe pathway to market for your medical device while ensuring your teams stay compliant.
Pharmaceutical
Embed industry-leading pharmaceutical quality processes that simplify and unlock FDA, ISO and ICH compliance.
Biotech
Beat the competition with quality-centric products that satisfy regulators, patients and stakeholders.
Cannabis
Earn regulatory trust and position your business for growth with a robust and quality-first approach.
Software as Medical Device
Unlock end-to-end control of your entire product lifecycle, connecting teams and cutting stress.
Contract Research Orgs
Deliver a compliant and continuously improving CRO service that delights clients and brings new ones flocking.
Our validation approach
- We do the heavy lifting, so you go live 2 weeks faster than traditional eQMS validation methods
- Built around the latest FDA and GAMP industry guidelines
- Pre-built templates and automated document packs accelerate or eliminate your validation tasks
- Only 1% of our customers choose to validate themselves!
Don't just take our word for it!
Hear from our many happy customers
“We’re building a quality product. So we bought a tool that gives us a quality culture. Instead of pushing quality to one department, Qualio breaks down that barrier.”
Daniel A.
Chief Technology Officer, InVivo Bionics
"When you're using paper, you're not moving forward. You can't.
Now we're so streamlined, we're finally making progress. We're talking about bringing a new product into design controls right now. I don't think that'd be possible if we didn't have Qualio."
Ami A.
Director of Ops & Quality Management, NeuFit
"I’ve never been more confident in my 27 years of being audited."
Lowell H.
Director of Quality Assurance, Restech
"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
"You're going to be able to get this thing in-house, validated, implemented and live in a short amount of time with limited resources.
That's unique in this industry."