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The International Medical Device Regulators Forum (IMDRF) has published a draft guidance (01 July, 2024) "Good machine learning practice...

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...

Jan 201 min read

WHO Guidance: Ethics and Governance of Artificial Intelligence for Health

The World Health Organization (WHO) released new guidelines (18 January 2023) on ethics and governance of large multi-modal models...

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Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...

Sep 21, 20223 min read

Artificial Intelligence in Regulatory Affairs

Artificial Intelligence (AI) is a broad term that encompasses many different things and is a kind of intelligence that is created by a...

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