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
MedFortis dashboard overview showing Pending Review, Reported, Total Flagged and AI Confidence tiles, plus the listing pipeline from AI discovery through human review to takedown
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 that share one evidence trail: a consolidated regulatory lookup, and continuous grey-market surveillance.

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 for every jurisdiction you sell into.

  • Six live sources: openFDA (US), MHRA (UK), Health Canada and Swissmedic for safety and enforcement notices, EU Safety Gate for consumer-channel and grey-market signals, plus EUDAMED for current EU device-registration status.
  • On-demand report annexes for post-market surveillance and PSUR submissions.
  • Adverse-event lookups served from continuously ingested data, so results come back 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: Google Shopping and DotMed monitored by default, with eBay (Browse API) and LabX activated for your account on request.
  • AI vision verification decides device vs accessory, with a confidence score.
  • Seller pattern detection links repeat and coordinated sellers within your own watchlists, using signals like shared contact details, matching listings and recurring accounts.
  • Full pipeline: watchlist → scan → AI vision → review → evidence → takedown.
Inside MedFortis

A live dashboard your team actually opens.

Real screens from the running product, the same ones a compliance team opens every day.

MedFortis dashboard overview showing pending reviews, reported violations, AI confidence score and recent grey-market discoveries
Dashboard — the listing pipeline from AI discovery through human review to takedown.
MedFortis watchlists screen showing monitored devices, authorized sellers, folders and scan usage
Watchlists — monitored devices, authorized sellers and scan usage, organized per product line.
Across both features

Built for teams that have to prove it.

Evidence & audit

Every finding is captured and hashed the moment it's flagged. Delete access is revoked at the database level, not only in the application, so the trail can't be edited after the fact. Generate an audit-ready PDF on demand for any takedown or report.

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 sits unnoticed.

Enterprise & security

A dedicated, isolated cloud environment per customer, provisioned and torn down by automation rather than by hand. Includes MFA, OIDC SSO, SCIM provisioning, M2M API keys and continuous automated testing against cross-tenant data leaks.

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. openFDA (United States), MHRA (United Kingdom), Health Canada and Swissmedic (Switzerland) supply safety and enforcement notices. EU Safety Gate, the EU's rapid alert system for dangerous consumer products, surfaces devices sold through consumer and resale channels outside normal medical distribution. EUDAMED (European Union) adds a device's current on-market registration status.
Does MedFortis find grey-market and unauthorized listings?
Yes. MedFortis continuously scans marketplaces: Google Shopping and DotMed by default, with eBay and LabX available on request. It uses AI image analysis to decide device vs accessory with a confidence score, links repeat and coordinated sellers within your own watchlists, and preserves evidence to drive 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 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. Every action is logged with a user ID and timestamp in that write-once audit trail, and an audit-ready PDF can be generated on demand for any takedown, case file or report. That's the evidence FDA 21 CFR Part 11 and EU MDR post-market surveillance rules require.
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: we run MedFortis against your device lines and show you, live, what's currently surfacing across six regulators and the resale market. You'll 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.

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