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Apr 16, 20232 min read

IMDRF Guidance: CyberSecurity, Post-Market Surveillance, Personalized Medical Devices

Recently (IMDRF) released new four technical guidelines, "Personalized Medical Devices – Production Verification and Validation",...

Oct 7, 20221 min read

USFDA MD Guidance: Postmarket Surveillance & Procedures for Handling Post-Approval Studies

USFDA's Center for Devices and Radiological Health released two updated, finalized guidelines yesterday and earlier today...