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Sharan Murugan
Feb 13 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)Â has released its final guidance document (IMDRF/AIML WG/N88:2025)Â outlining...
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Sharan Murugan
Apr 16, 20232 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",...
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Sharan Murugan
May 11, 20221 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...
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Sharan Murugan
Jul 10, 20211 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...
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