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Sharan Murugan
- Sep 15
- 2 min
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...
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Sharan Murugan
- Jul 15
- 2 min
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...
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Sharan Murugan
- Jul 3
- 2 min
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The International Medical Device Regulators Forum (IMDRF) has published a draft guidance (01 July, 2024) "Good machine learning practice...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
- May 18
- 2 min
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...
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Sharan Murugan
- May 6
- 2 min
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...
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Sharan Murugan
- Jan 23
- 2 min
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...
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Sharan Murugan
- Oct 25, 2023
- 1 min
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...
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Sharan Murugan
- Mar 30, 2023
- 1 min
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Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...
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Sharan Murugan
- Oct 17, 2022
- 1 min
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,...
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