Search

Optimizing Standards for Regulatory Use

Definitions for Personalized Medical Devices

Software as a Medical Device (SaMD): Clinical Evaluation

Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

Common Data Elements for Medical Device Identification

Medical Device Regulatory Audit Reports

Software as a Medical Device (SaMD): Application of Quality Management System

Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations

Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations

UDI Guidance: Unique Device Identification (UDI) of Medical Devices