Practical guides on FDA and EU MDR compliance, adverse-event and recall monitoring, PSUR reporting, and protecting your devices in the open market.
How to access the FDA MAUDE adverse-event database (web search, openFDA API, bulk downloads), scope and run a repeatable monitoring workflow, and the limitations to respect.
Read article →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 →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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