April 2026 Update for FDA QMSR Inspection Results

Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact April 2026 Update for FDA QMSR...

When a Small Process Failure Becomes a Patient Safety Event

Medical Device Safety Alert Erbe cryoprobes may rupture or burst Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact What the...

When a “Good Enough” Design May Fail the User

When a “Good Enough” Design May Fail the User A Case Study in Usability Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers Advancing from Basic Design to Usability In a world...

Postmarket Surveillance

Postmarket Surveillance Requirements for PMS in the US and EU Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers What is Postmarket Surveillance (PMS)? Postmarket surveillance...