From CSV to CSA: A New Era in Computer System Assurance
The Importance of Clinical Evaluation in Medical Device Development
Misuse and Use Error: Usability Engineering in Medical Device Design
Public Comments Solicitation on the Proposed Ordinance Amending the Ordinance Regarding Standards for Manufacture Control and Quality Control of Medical Devices and In Vitro Diagnostic Devices
Clinical Evaluation and Performance Evaluation in Medical Device Regulation
FDA Medical Device Quality System Regulation (QSR) Amendment: Current Status and Industry Impact
Design Transfer: Definition, Requirements, and Implementation
Clinical Evaluation and Performance Evaluation