Guides
Reference guides for device safety
Plain-English explainers on the data and methods behind medical device post-market surveillance. Start here, then put them to work in the free MAUDE lookup.
FDA MAUDE Database: What It Is and How to Use It
What the FDA MAUDE database contains, who files reports, how to search it, and the limits to know before you trust the counts.
Post-Market Surveillance: A Practical Guide
The U.S. regulatory framework, the data sources teams rely on, and why detecting signals is harder than collecting events.
Safety Signal Detection for Medical Devices
What a safety signal is, why raw counts mislead, and the detection methods that turn noisy adverse event data into something actionable.