On Usability
MDR Vigilance System: Building Comprehensive Post-Market Surveillance for Medical Devices
Differences Between Pharmaceutical and Medical Device Regulations Regarding Engineering Design
Document and Record Management in Regulated Industries
Revisions to Japan’s Medical Device Quality Management System Ordinance
Distinguishing Between “Misuse” and “Use Error” in Medical Device Regulation
Regarding “Heavy” Quality Management Systems
FDA Recognition of ISO 14971:2019 as a Consensus Standard