VeriPathKnow your gaps before the auditor does.
VeriPath checks your technical documentation against the exact EU IVDR requirements that apply to your device's risk class, then tells you what's missing, what's weak, and what's ready, with a citation back to the requirement itself.
Built for medtech companies and the regulatory affairs teams who support them.
From documentation to clarity in minutes
Create your device profile
Name, risk class (A, B, C, or D), and target markets. That's what determines exactly which IVDR requirements apply to you.
See what a finding looks like
Three examples of the detail behind every VeriPath finding: an annex reference, a verdict, and reasoning traced back to the specific requirement.
SteriCol U-120
Sterilant residue testing
MissingThe device is sterilised with ethylene oxide, so testing for ethylene oxide and ethylene chlorohydrin residues under EN ISO 10993-7 is squarely applicable... the manufacturer has identified the hazard in its risk analysis and then produced no data on the residual level, so the risk control cannot be verified.
ImmunoWash 20X
Intended purpose statement
WeakThe intended purpose is clearly and correctly stated... What is absent from the statement is the intended user... Annex II 1.1(a) requires the intended purpose statement itself to identify the intended users.
CytoFix CF-2
Clinical performance
Ready for SubmissionClinical performance is treated as applicable and is demonstrated, not disposed of by assertion... nine characteristics from Annex I 9.1(b) with point estimates and confidence intervals from a prospective study.
Every finding shows its work.
VeriPath isn't a black-box opinion generator. Two things make that possible.
Built to make regulatory review faster, not to replace the judgment of the people who do it.
A curated, version-controlled EU IVDR requirements database, reviewed and maintained by a qualified regulatory affairs specialist. Not scraped once and left to go stale.
The AI is constrained to cite the specific requirement ID and regulatory version behind every finding. If it can't point to a clause, it doesn't make a claim.
IVDR compliance gaps cost medtech companies months of delay and thousands in consultant fees.
Most medtech companies find out about documentation gaps only after submitting to a notified body, when it's already too late. VeriPath gives you that visibility upfront, so your regulatory team spends its time closing gaps instead of finding them.
VeriPath doesn't replace your judgment. It triages the first pass, so client engagements start from a documented baseline instead of a blank read-through.
Built for European regulatory compliance
EU IVDR
2017/746
In Vitro Diagnostic Regulation
European coverage today. Global reach next.
Here's where VeriPath is headed as we expand coverage beyond the EU.
Current focus
- EU IVDR (2017/746)
Coming next
- EU MDR (2017/745)
- UKCA
MDSAP markets
- Australia (TGA)
- Brazil (ANVISA)
- Canada (Health Canada)
- Japan (PMDA)
- USA (FDA)
Know your gaps before the auditor does.
Request early access and we'll be in touch about joining as a design partner.