When a Small Process Failure Becomes a Patient Safety Event

by | Mar 23, 2026 | Analysis, Editorial, ISO 14971, Med-Devices, Product Design, Product Quality, Products_Devices, QMSR, Quality system, Reg_Information, Reg_Products, US-FDA

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 Apparel Becomes a Medical Device

by | Mar 4, 2026 | Analysis, Device Warning Letters, FDA Enforcement, Industry Information, Industry News, Labeling, Med-Devices, Medical Device Labeling, Reg_Information, Regulatory_Info, US-FDA

MDP Regulatory Insight When apparel becomes a medical device Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact Lessons from FDA’s Breast Binder Warning...

When a “Good Enough” Design May Fail the User

by | Nov 6, 2025 | Design and Development, Design Changes, FDA Regulations, Human Factors, Industry News, International standards, ISO 13485, ISO 14971, Med-Devices, Product Design, Product Quality, QMSR, Safety, US-FDA

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...