About MedFortis

What we do

Medical device manufacturers are responsible for knowing what regulators and the open market are saying about their devices — and 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, map coordinated sellers, preserve evidence and drive takedowns of unauthorised, diverted or counterfeit listings.

Every finding is captured, hashed and audit-logged — the documented, defensible 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.