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...
by MDP Staff | Jul 24, 2025 | EU MDR, FDA Reports, Global-RA, Industry Information, MDR - Medical Device Report, Med-Devices, US-FDA
Global Medical Device Reporting and Vigilance Reporting serious safety risks Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact International Medical Device Reporting Medical Device Reporting and...
by MDP Staff | Jul 24, 2025 | Alerts, Alerts-Device, Cannula, Cardiovascular, Class I Recalls, Med-Devices, Product Recalls
Recall Alert: Edwards Lifesciences Arterial Cannulae Risk of wire exposure near the cannula tip Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Edwards Lifesciences Arterial CannulaSource: FDA...
by MDP Staff | Jul 24, 2025 | Alerts-Device, Class I Recalls, Med-Devices, Product Recalls
Device Recall: ZOLL AutoPulse NXT Resuscitation System Device may fail to deliver adequate CPR Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Urgent Class I Medical Device Recall ZOLL...
