Post-Market Surveillance for Medical Devices
Filter official FDA and Health Canada regulatory signals by your device profile. Scored with reasons, reviewed by your RA/QA team, exported as inspection-ready evidence. Less effort, less risk, always inspection ready.
Last updated: February 2026
Why RA/QA Teams Need Better PMS Tools
Missing Critical Signals
FDA and Health Canada publish thousands of signals monthly. Manual keyword searches miss relevant recalls, clearances, and enforcement actions.
Hours of Manual Review
Without scoring, every signal looks the same. RA/QA engineers waste time reviewing irrelevant results instead of focusing on what matters.
Audit Trail Gaps
When inspectors ask for PMS evidence, teams scramble to prove what they reviewed, when, and why. Spreadsheets are not audit-ready.
How TrueMedDevice PMS Monitoring Works
Step 1: Define Your Device Profile
Enter your device name, keywords, and FDA product codes. Takes less than 2 minutes.
Step 2: Filter & Score Signals
Records are filtered to your device. Each signal scored HIGH, MID, or LOW with reasons.
Step 3: RA/QA Team Reviews
Your team reviews scored signals. Approve & save, or override with your own judgment and reasoning.
Step 4: Export Inspection-Ready Evidence
Export reviewed signals as CSV with audit trail and coverage statement. Always inspection ready.
Official FDA and Health Canada Sources
All data comes directly from FDA and Health Canada official APIs. Updated regularly.
Start your post-market surveillance in under 2 minutes
Free account. No credit card required. Set up your device profile and start reviewing scored signals immediately.
Create free accountFrequently Asked Questions
What is post-market surveillance for medical devices?
Post-market surveillance (PMS) is the systematic process of collecting, analyzing, and acting on information about medical devices after they have been placed on the market. It is required by FDA (21 CFR 803, 806, 822), Health Canada (SOR/98-282), ISO 13485 Section 8.2.1, and the EU MDR Article 83-86.
Who is required to perform post-market surveillance?
All medical device manufacturers, importers, and device user facilities that market devices in regulated jurisdictions are required to maintain PMS programs. Under FDA regulations, this includes MDR reporting (21 CFR 803), correction/removal reporting (21 CFR 806), and quality system requirements (QMSR/21 CFR 820).
What data sources should a PMS program monitor?
A comprehensive PMS program should monitor adverse event databases (FDA MAUDE, Health Canada), recall and enforcement actions, 510(k) clearances and PMA approvals for competitor intelligence, complaint data, published literature, and field safety notices from relevant regulatory authorities.
How often should PMS data be reviewed?
PMS data should be reviewed continuously or at regular intervals appropriate to the device risk class. Health Canada requires annual summary reports for Class III/IV devices and biennial reports for Class II. MDSAP auditors expect evidence of systematic, ongoing review.
What is an inspection-ready evidence pack?
An inspection-ready evidence pack is a structured collection of documents that demonstrates your PMS monitoring activities, triage decisions, and disposition rationale. It should include who reviewed what signals, when, why they made their determination, and traceable citations back to authoritative regulatory sources.