MedFortis
Regulatory intelligence for medical devices

Six regulators. One lookup.

MedFortis™ consolidates safety and enforcement notices, adverse events and report annexes from six regulators into a single device search — and finds your devices on the resale market, with audit-ready evidence for every finding.

Book a Demo → See how it works
openFDA · MHRA · Health Canada EU Safety Gate · Swissmedic · EUDAMED AI-verified marketplace findings
2 safety noticesMHRA · Model SX2
Listing AI-verifiedeBay · takedown issued
Infusion Pump — Model SX2One search · six regulators + the open market
Consolidated
6
Regulators searched
9
Notices found
3
Listings verified
Consolidated results · one search0.9s
openFDA4 adverse events
MHRA2 safety notices
Health Canada1 recall
EU Safety Gate1 alert
Swissmedicclear
EUDAMED1 notice
Resale market · 4 marketplaces3 flagged
Aligned with the standards your auditors check
FDA 21 CFR 820 EU MDR 83–92 21 CFR Part 11
Two jobs, one platform

Look it up. Then keep watch.

Two co-equal features — a consolidated regulatory lookup and continuous grey-market surveillance — sharing one evidence trail.

Regulatory Product Lookup

Search a device, see everything at once.

One search returns consolidated safety and enforcement notices, adverse events and on-demand report annexes — across every jurisdiction you sell into.

  • Six live sources — openFDA (US), MHRA (UK), Health Canada, Swissmedic and EUDAMED, plus EU Safety Gate for consumer-channel and grey-market signals.
  • On-demand report annexes for post-market surveillance and PSUR submissions.
  • Adverse-event lookups served from continuously ingested data — fast and repeatable.

Grey-Market Surveillance

Find your devices on the resale market.

Continuously watches marketplaces for your devices, verifies each listing with AI image analysis, preserves the evidence and drives takedowns.

  • Marketplace coverage — eBay (Browse API), Google Shopping, DotMed, LabX.
  • AI vision verification decides device vs accessory, with a confidence score.
  • Seller-network graph links coordinated and repeat sellers into patterns.
  • Full pipeline — watchlist → scan → AI vision → review → evidence → takedown.
Across both features

Built for teams that have to prove it.

Evidence & audit

Every finding captured, hashed and preserved as a PDF — with a full, write-once audit trail behind it.

Review workflow

A triage queue with assignment, notes and status — plus bulk device import from FDA GUDID by UDI.

Alerts & analytics

Notification centre, email alerts, webhooks and dashboards — so nothing waits for someone to go looking.

Enterprise & security

An isolated environment per customer, MFA, OIDC SSO, SCIM provisioning, M2M API keys and a full audit trail.

Trust

Isolated, preserved, defensible.

1:1
A dedicated, isolated cloud environment per customer
6+4
Regulators and marketplaces, consolidated in one platform
100%
Findings captured, hashed & audit-logged
FAQ

Regulatory intelligence, answered.

What does MedFortis do?
MedFortis is a regulatory intelligence platform for medical device manufacturers with two core features. Regulatory Product Lookup: search a device once and see consolidated safety and enforcement notices, adverse events and on-demand report annexes from six regulators. Grey-Market Surveillance: continuously watch resale marketplaces, verify listings with AI image analysis, preserve evidence and drive takedowns.
Which regulators does MedFortis cover?
Six regulatory sources, consolidated in one lookup. Five are medical-device regulators — openFDA (United States), MHRA (United Kingdom), Health Canada, Swissmedic (Switzerland) and EUDAMED (European Union) — plus EU Safety Gate, the EU's rapid alert system for dangerous consumer products, which surfaces devices sold through consumer and resale channels outside normal medical distribution.
Does MedFortis find grey-market and unauthorized listings?
Yes. MedFortis continuously scans marketplaces including eBay, Google Shopping, DotMed and LabX, uses AI image analysis to decide device vs accessory with a confidence score, maps coordinated sellers into networks, preserves evidence and drives takedowns.
Can MedFortis support EU MDR post-market surveillance (Articles 83–92)?
Yes — post-market surveillance is a key use case. MedFortis consolidates the external signals your PMS plan must cover — adverse events, safety and enforcement notices, and open-market activity — and generates on-demand report annexes that feed your PMS report or PSUR under EU MDR Articles 83–92 and FDA 21 CFR 820.
Is the evidence audit-ready for 21 CFR Part 11 and EU MDR?
Every finding is captured, hashed and preserved as a PDF, and every action is recorded with a user ID and timestamp in a write-once audit log — the documented, defensible trail required under FDA 21 CFR Part 11 and EU MDR post-market surveillance rules.
How is MedFortis deployed and secured?
Each customer runs in an isolated, dedicated cloud environment. Access is protected with multi-factor authentication, OIDC single sign-on and SCIM provisioning, machine-to-machine API keys for integrations, and a full audit trail.
What happens in a demo?
A demo is a free 30-minute session where we run MedFortis against your device lines and show you, live, what's currently surfacing across six regulators and the resale market — so you can see what you're missing before committing to anything.

See what you're missing — across six regulators and the open market.

We'll run MedFortis against your device lines, live: one lookup across openFDA, MHRA, Health Canada, EU Safety Gate, Swissmedic and EUDAMED — plus the resale market.

Free 30-minute session · we'll find a time that suits you

Book a demo

Tell us about your device lines and we'll reply within one business day to set it up.

Please enter your name.
Please enter a valid work email.
Please enter your company.