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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
Jul 3, 20242 min read
IMDRF Guidance: Good Machine Learning Practice for Medical Device Development: Guiding Principles
The International Medical Device Regulators Forum (IMDRF) has published a draft guidance (01 July, 2024) "Good machine learning practice...
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Sharan Murugan
Jun 15, 20242 min read
UK MHRA Guidance: Machine Learning Medical Devices: Transparency Principles
Last Thursday (13 June 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Machine...
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Sharan Murugan
Mar 30, 20231 min read
USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...
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