Regulatory clarity
for medical device teams
Upload your device documentation and get an instant gap analysis against EU MDR 2017/745 and IVDR 2017/746 requirements — categorised, traceable, and ready to act on.
Stop guessing. Know exactly where your EU MDR and IVDR submission stands before it hits a notified body.
Built for EU MDR and IVDR. Designed for small medtech teams.
From documentation to clarity in minutes
Upload your technical documentation
Drop your device files, technical documentation, and clinical data. We support PDFs, Word docs, and structured data formats.
AI maps against live requirements
Our AI cross-references your documentation against current MDR and IVDR requirements, specific to your device classification.
Receive your gap report
Get a categorised assessment: Missing, Weak, or Looks Good — with traceable references to specific regulatory clauses.
MDR and IVDR compliance failures cost startups months of delay and thousands in consultant fees.
Most small medtech teams discover critical documentation gaps only after submitting to a notified body — when it's already too late. VeriPath gives you that visibility upfront, so you can fix issues before they become costly delays.
Built specifically for startups and solo regulatory affairs consultants who need enterprise-level compliance insight without the enterprise budget.
Built for European regulatory compliance
EU MDR
2017/745
Medical Device Regulation
EU IVDR
2017/746
In Vitro Diagnostic Regulation
Additional frameworks coming soon