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IMDRF documents

Technical document

13 April 2023

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

Technical document

11 April 2023

Personalized Medical Devices – Production Verification and Validation

Technical document

11 April 2023

Principles and Practices for the Cybersecurity of Legacy Medical Devices

Outcome statement

27 September 2022

Australia Virtual Meeting outcome statement

Outcome statement

14 June 2022

Australia Virtual Meeting outcome statement

Information document

13 May 2022

IMDRF Standards Liaison Program Framework

Technical document

9 May 2022

Machine Learning-enabled Medical Devices: Key Terms and Definitions

Outcome statement

19 November 2021

Korea Virtual Meeting outcome statement

Technical document

20 October 2021

Regulatory Authority Assessor Competence and Training Requirements

Technical document

20 October 2021

Competence and Training Requirements for Auditing Organizations