Product development runs on software, AI and continuous delivery. Quality and compliance still run on spreadsheets, shared drives and people remembering. The proof lags the product, and a quality team holds it all together by hand. So we connected all three.
The agentic compliance platform for life sciencesRun quality, ship regulated products
Run quality, ship regulated products
and prove compliance
Qualio works with the tools your teams already use, so quality, product and compliance stay connected without anyone holding them together.
Trusted by over 700 customers from startup to scaleup, and beyond
One connected system
Product development has changed. Quality and compliance haven't.
99%
Less time on quality admin.
Akadeum Life Sciences<60 days
To go live.
30 Technology$130K
Saved on staff and consultants.
Neufit6 months
To ISO 13485, no new hires.
CardiaccsRun quality in one system your whole company uses
- eQMS
- document control
- training
- CAPA
- change control
- supplier quality
Take a regulated product from idea to release
- design controls
- traceability
- ISO 14971
- IEC 62304
- technical documentation
- 510(k)
LogixX Pharma
LogixX Pharma reduced consultant spend by 60%, reached audit readiness 80% faster, and delivered a verified 5x ROI.
The same records, put to work
A traditional QMS stores records. Qualio acts on them.
Traditional QMSSystem of record
System of action
Where quality and product work live
Separate tools
Single centralized platform
What it does with your records
Stores compliance artifacts
Traces every link and raises issues early
How you get ready for an audit
Audit prep as costly, time-consuming sprints
Always audit ready, as work happens
Where AI fits
Basic AI assistants
ISO 42001-certified AI, approval-gated
Copilot and agents
Qualio does the work. Your team approves.
Qualio's AI assesses your records clause by clause, puts a recommendation on every gap and drafts the fix: a procedure, a change control or a CAPA, with the clause and the record cited. Your team approves, and when a record changes the assessment runs again.
Jira
Google
OneDrive
GitLab
Linear
Asana
GitHub
IntercomTrust is designed into the system
Qualio works from your controlled records and your connected product data
Every output cites the clause it applied and the record it read
Nothing enters your quality system without a human approval, recorded with who, when and on what evidence
A validation pack ships with every major release; certified to ISO 9001, ISO 27001, ISO 27701 and ISO42001
Built for quality, regulatory and engineering teams
Quality leaders
One system the whole company uses, live in under 60 days.
Heads of Product and Engineering
Engineers stay in Jira and GitHub, and the traceability rebuilds itself.
Regulatory affairs
Every standard you're audited against, assessed clause by clause.
Hear from our customers
“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 Hue
Head of Quality & GxP Compliance, 30 Technology
“Qualio surfaces gaps automatically. We resolve issues faster and walk into audits with confidence.”
Christophe Dohr
Site Quality Manager, Sentec
“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
