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UK MHRA Press Release Trials Innovative AI Technologies in Regulatory Pilot Scheme
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has launched (4th December 2024) a groundbreaking pilot scheme "...

Sharan Murugan
Dec 4, 20242 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...

Sharan Murugan
Sep 15, 20242 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...

Sharan Murugan
Jul 15, 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The International Medical Device Regulators Forum (IMDRF) has published a draft guidance (01 July, 2024) "Good machine learning practice...

Sharan Murugan
Jul 3, 20242 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...

Sharan Murugan
May 18, 20242 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...

Sharan Murugan
May 6, 20242 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...

Sharan Murugan
Jan 23, 20242 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...

Sharan Murugan
Oct 25, 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Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...

Sharan Murugan
Mar 30, 20231 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,...

Sharan Murugan
Oct 17, 20221 min read
