by Bruce Waldon | Mar 23, 2026 | Alerts, Alerts-Device, Industry Information, Industry News, Med-Devices, MedWatch-System, Product Safety, Safety, 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 FDA Flags...
by Bruce Waldon | Mar 19, 2026 | EtO, Industry Information, Industry News, Med-Devices, Products_Devices, Sterilization, US-FDA
EtO Regulation Rollback EPA seeks to weaken emissions restrictions Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact EPA...
by Bruce Waldon | Mar 4, 2026 | FDA Approvals, Med-Devices, New devices, Product-Innovation, US-FDA
Medical Device Innovation Optune Pax treats pancreatic cancer with TTFields therapy Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR...
by Bruce Waldon | 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...
by Bruce Waldon | 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...
by MDP Staff | Jul 25, 2025 | Alerts, Alerts-Device, Class I Recalls, FDA Safety Communication, Industry News, Med-Devices, Product Recalls, Product Safety, Safety, Surgical
Ethicon Issues Safety Alert for Endopath Echelon Vascular Reload Surgical Stapler Cartridge Correction Home About Consumer Medical Devices Pharma Biologics Biologics Warning Letters AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Endopath...
