IMDRF documents

Personalized Medical Devices - Regulatory Pathways

Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity

Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form

Principles and Practices for the Cybersecurity of Legacy Medical Devices

Personalized Medical Devices – Production Verification and Validation

Medical Device Regulatory Review Report: Guidance Regarding Information to be Included

IMDRF Standards Liaison Program Framework

Machine Learning-enabled Medical Devices: Key Terms and Definitions

MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization

Competence and Training Requirements for Auditing Organizations