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Sep 152 min read

EMA: Harnessing AI in Medicines Regulation: The Role of Large Language Models (LLMs)

The advancement of Artificial Intelligence (AI) is transforming many industries, and the pharmaceutical and regulatory sectors are no...

Jul 152 min read

New EU Regulations on AI in Medical Devices: Key Insights and Implications

The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...

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The International Medical Device Regulators Forum (IMDRF) has published a draft guidance (01 July, 2024) "Good machine learning practice...

May 182 min read

UK MHRA: "AI Airlock" The Regulatory Sandbox for AIaMD

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced (09 May, 2024) the “AI Airlock - The Regulatory Sandbox...

May 62 min read

UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device

Last Friday (03 May 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Software and...

Jan 232 min read

USFDA's ISTAND Pilot Program: Accepts First Submission of AI-Based Digital Tech for Neuroscience

A new submission has been accepted into the FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program by...

Oct 25, 20231 min read

UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device

Earlier today (25 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Software...

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Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...

Oct 17, 20221 min read

UK's MHRA Guidance: Software & AI as a Medical Device Change Programme

The Medicines and Healthcare Products Regulatory Agency (MHRA) has begun reforming medical device regulation to ensure software,...