Topic
Post-Market Surveillance
2 articles
Regulatory
FDA MAUDE Database: The Complete Guide to Searching and Using Medical Device Adverse Event Reports
How to search, interpret, and use the FDA MAUDE database — report types, data fields, search techniques, limitations, and practical applications for regulatory professionals.
70 min read2026-03-25
›Post-Market Surveillance
Post-Market Surveillance for Medical Devices: The Complete Guide
Everything you need to know about post-market surveillance (PMS) for medical devices — regulatory requirements under FDA and EU MDR/IVDR, PMS plan templates, PMCF studies, PSURs, vigilance reporting, and practical guidance for building a PMS system from scratch.
59 min read2026-03-18
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