Buyer's guide
How to Choose Post-Market Surveillance Software
Seven evaluation criteria, red flags to watch for, the questions that separate marketing from capability, and an evaluation checklist.
Read article →Category guide
What Is Regulatory Intelligence Software for Medical Devices?
What the category covers, the four jobs it does, how it differs from a QMS, who uses it, and the one-question test for any tool.
Read article →Brand protection
Grey-Market Medical Devices: How Diversion Happens and How to Stop It
Why unauthorized resale listings are a safety and liability risk, how devices end up on eBay, DotMed and LabX, and the watchlist-to-takedown workflow that stops them.
Read article →Global
Beyond the FDA: Monitoring Global Medical Device Regulators
What MHRA, Health Canada, EU Safety Gate, Swissmedic and EUDAMED each publish, why signals surface in one jurisdiction first, and how to consolidate all six sources.
Read article →MHRA / UK
MHRA Field Safety Notices & Medical Device Alerts: How to Monitor Them
FSNs vs MHRA alerts, where they're published on GOV.UK, Yellow Card reporting, the GB/Northern Ireland split, and how to monitor UK device safety information post-Brexit.
Read article →Technical
openFDA Device Event API: How to Query FDA MAUDE Programmatically
A developer's guide to api.fda.gov/device/event.json — search syntax, counting (the .exact rule), pagination, rate limits, API keys and the gotchas, with real working queries.
Read article →FDA
FDA MAUDE Database: How to Search & Monitor Adverse Events
How to search the FDA MAUDE database (web search, openFDA API, bulk downloads), scope and run a repeatable monitoring workflow, and the limitations to respect.
Read article →EU MDR
PSUR vs PMS Report: What's the Difference?
Which EU MDR device classes need a PSUR vs a PMS Report, what goes in each, how often to update them, and who reviews them — with a side-by-side comparison.
Read article →EU MDR
EU MDR Article 83–92: Post-Market Surveillance Requirements Explained
What Articles 83–92 actually require — the PMS system, PMS plan, PSUR, serious-incident reporting timelines and trend reporting, explained in plain terms.
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