Four validated tools for medical device quality teams — end-to-end event tracking, MDSAP readiness, DHF gap assessment, and QMS compliance benchmarking.
Why MedQA Launch
Identify deviations from ISO 13485, FDA 21 CFR Part 820, and EU MDR before they become audit findings — not after.
Replace spreadsheet checklists with a dynamic MDSAP readiness assessor that scores your posture in real time based on your actual company profile.
When you acquire a company you inherit their quality debt. Our DHF gap assessment maps the delta before it becomes a regulatory liability.
Platform
Plug into your existing infrastructure and gain instant visibility over every quality event — from triage and CAPA assignment through to escalation and final closure. Every step documented, timestamped, and audit-ready.
Answer structured questions about your company and product portfolio. The tool scores your readiness across all five MDSAP jurisdictions and prioritises remediation actions.
Post-acquisition, the last thing you need is a regulatory surprise buried in an acquired company's DHF. This tool maps the delta between your QMS and their design history.
A structured assessment that evaluates your local QMS against current ISO 13485, FDA 21 CFR Part 820, EU MDR/IVDR, and other applicable frameworks — producing an actionable posture report.
MedQA Launch tools are designed by professionals with decades of hands-on experience in medical device quality, regulatory affairs, and compliance management across FDA, EU MDR, and MDSAP jurisdictions. Every workflow reflects how auditors think — not just what the standards say.
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Placeholder — industry feedback coming soon.
Placeholder — industry feedback coming soon.
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