Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

Jul 32 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The International Medical Device Regulators Forum (IMDRF) has published a draft guidance (01 July, 2024) "Good machine learning practice...

Jun 152 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...

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Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...