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IMDRF Guidance on Supplier Controls for Medical Devices: Overview of QMS Expectations
The International Medical Device Regulators Forum (IMDRF) continues to strengthen global harmonisation of medical device quality management systems (QMS) through updated guidance focused on supplier controls and risk-based oversight. A major development in this area is the draft guidance titled “Guidance on the Control of Products and Services Obtained from Suppliers ”, published by the IMDRF Quality Management Systems Working Group. The IMDRF draft guidance provides detailed
Sharan Murugan
May 172 min read
IMDRF Med Dev Guidance: Good Machine Learning Practice (GMLP) for Medical Device Development: IMDRF’s Guiding Principles
The International Medical Device Regulators Forum (IMDRF) has released its final guidance document (IMDRF/AIML WG/N88:2025) outlining...
Sharan Murugan
Feb 1, 20253 min read
IMDRF Guidance: CyberSecurity, Post-Market Surveillance, Personalized Medical Devices
Recently (IMDRF) released new four technical guidelines, "Personalized Medical Devices – Production Verification and Validation",...
Sharan Murugan
Apr 16, 20232 min read
Cybersecurity of Legacy Medical Devices - Guidance-IMDRF
The International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Guide (MDCG) Working Group Proposed document...
Sharan Murugan
May 11, 20221 min read
Assessment & Decision Process for the Recognition of a Conformity Assessment Body -IMDRF
International Medical Device Regulators Forum (IMDRF) published a final document describing the “Assessment and Decision Process for the...
Sharan Murugan
Jul 10, 20211 min read