Has Industry Self-Regulation Been Effective? 

Supplement Industry Self-Regulation Mixed results related to manufacturer prominence Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Has Industry Self-Regulation...

The 30-Year Consequences of Faulty Supplement Legislation

The 30-Year Consequences of DSHEA A direct cause of the supplement safety crisis Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact How a 1994 Law Created Today’s...

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...

Ethicon Issues Safety Alert for Surgical Stapler Cartridge

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...