MedFortis
New · Free PMS Gap Scan

Post-market surveillance, on autopilot.

MedFortis watches FDA data, recalls, trials and the open market for your devices — continuously — and turns it all into audit-ready evidence in minutes, not weeks.

Get your free PMS Gap Scan → See how it works
FDA 21 CFR 820 EU MDR Art. 83–92 21 CFR Part 11
3 new adverse eventsFDA MAUDE · Model SX2
Takedown issued2 unauthorized listings
Infusion Pump — Model SX2Portfolio · cross-referenced live
Monitoring
412
Signals watched
7
Flagged
5
Resolved
Signals · last 7 days+18%
Composite riskElevated
Aligned with the standards your auditors check
FDA 21 CFR 820 EU MDR 83–92 21 CFR Part 11 HIPAA
Why teams choose MedFortis

Surveillance that's complete, continuous, and provable.

The three things a post-market auditor actually checks — handled for you.

Complete

Every external signal in one platform — FDA data, recalls, trials and the open market. No blind spots between databases.

Continuous

Always-on monitoring, not a manual sweep every quarter. You're current by default — never scrambling before an audit.

Provable

A timestamped, tamper-evident evidence trail built as you go — the exact record an auditor asks to see.

What we watch

One platform for every source you track by hand.

Adverse events

FDA MAUDE injuries & malfunctions, surfaced as they post.

Recalls

Active FDA/EU recall matches, including shadow recalls.

Clinical trials

Investigational or trial-restricted units on the open market.

Price & anomaly

Below-market pricing that signals diverted or fake stock.

Seller networks

Connected & repeat sellers mapped into patterns.

Grey-market listings

Unauthorized listings, AI-verified down to the Rx-only label.

The difference

From weeks of manual work to minutes.

12+
Live sources watched, continuously
Weeks→Min
Time to surface a new signal
100%
Actions logged & audit-ready
FAQ

Post-market surveillance, answered.

What is post-market surveillance (PMS) software?
Post-market surveillance software continuously monitors a medical device after it reaches the market — tracking adverse events, recalls and field signals — so manufacturers can meet their obligations under FDA 21 CFR 820 and EU MDR Articles 83–92. MedFortis automates this monitoring across public data sources and the open market.
How does MedFortis automate FDA and EU MDR surveillance?
MedFortis continuously scans sources like the FDA MAUDE adverse-event database, recall notices and clinical-trial registries, cross-references each signal against your device portfolio, scores it by risk, and compiles audit-ready reports that feed your PMS plan and PSUR.
Does MedFortis monitor grey-market and unauthorized listings?
Yes. MedFortis detects unauthorized and grey-market medical device listings on marketplaces such as eBay and Google Shopping, using AI image verification to confirm the device down to the Rx-only label and serial pattern.
Is the evidence audit-ready for 21 CFR Part 11 and EU MDR?
Every action is recorded with a user ID, timestamp and tamper-evident hash in a write-once audit log, producing the documented, defensible trail required under FDA 21 CFR Part 11 and EU MDR post-market surveillance rules.
What is a PMS Gap Scan?
A PMS Gap Scan is a free 30-minute session where we run MedFortis against your device lines and show you, live, what's currently surfacing across FDA data, recalls, trials and the open market — so you can see your real surveillance gaps before committing to anything.
Who is MedFortis for?
MedFortis is built for regulatory affairs, compliance, quality and brand-protection teams at medical device manufacturers who are responsible for post-market surveillance.

See what your post-market surveillance is missing.

We'll run MedFortis against your device lines, live, and show you what's surfacing across FDA data, recalls, trials and the open market.

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

Request your free PMS Gap Scan

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

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