About MedFortis

What we do

Medical device manufacturers are responsible for knowing what regulators and the open market are saying about their devices. Today that means watching a dozen government databases and marketplaces by hand. MedFortis replaces that manual work with one platform, built around two jobs:

• Regulatory Product Lookup: one search consolidates safety and enforcement notices, adverse events, recalls and report annexes for a device from regulators across the US, UK, EU, Canada and Switzerland, plus clinical-trial registries. One lookup instead of a dozen websites.
• Grey-Market Surveillance: continuous monitoring of major e-commerce marketplaces for a manufacturer's devices, using an AI vision pipeline to verify listings, link repeat and coordinated sellers within a manufacturer's own watchlists, preserve evidence and drive takedowns of unauthorised, diverted or counterfeit listings.

Every finding is captured and hashed automatically the moment it's flagged, with delete access revoked at the database level so the record can't be edited after the fact. That's the trail manufacturers need for their post-market surveillance obligations under FDA 21 CFR 820, 21 CFR Part 11 and EU MDR Articles 83–92.

The problem we solve

Unauthorised resellers, grey-market listings and counterfeit products routinely appear on major marketplaces, creating regulatory exposure and putting patients at risk from unverified devices. Meanwhile the formal regulatory picture for those same devices (adverse events, recalls, safety notices, terminated trials) lives in separate government databases nobody has time to watch continuously. MedFortis brings both into one surveillance workspace, so a compliance team sees signal, not noise, and can prove they acted.

Who it's for

MedFortis is built for the regulatory affairs, quality and brand-protection teams at medical device manufacturers who need a defensible, always-current post-market surveillance process, without hiring a team to search databases and marketplaces every week.