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Artificial intelligence articles

DIN SPEC 91509: A milestone for structured, digital medical device documentation

2026-01-30T12:29:00+00:00By Jack Bacon

This industry news update introduces a new model that will help with the digitalisation of documentation under EU law.

MHRA invites Call for Evidence to assess AI regulation
2026-01-27T15:25:00+00:00By Rebecca Harding
FDA and EMA publish guiding principles of good AI practice in drug development
2026-01-27T11:42:00+00:00By Rebecca Harding
2025 UK MDR Regulatory Conference: Meeting report
2026-01-14T09:46:00+00:00By John Wilkinson OBE, Steve Lee and Claire McDermott
The evolving role of the regulatory professional in the age of Artificial Intelligence
2026-01-14T09:45:00+00:00By Peter Lassoff
Empowering digital innovation in CMC: A framework for regulatory readiness and confidence
2026-01-14T09:44:00+00:00By Dr Ian Houson, Professor Walkiria Schlindwein, Dr Chantal Mustoe and Professor Daniel Markl
Overview of the regulatory and development landscape for brain-computer interfaces in neurodegenerative disease treatment
2026-01-14T09:39:00+00:00By Zabin Younes, Maria Beatrice Panico and Tauheed Ibrahim

MD7: Updates on Artificial Intelligence legislation and policy
2025-11-18T10:07:00+00:00By Hasnaa Fatehi
MD6: The importance of digital health – Digital Health Applications (DiGA) and the Digital Mental Health Technology Project
2025-11-18T10:06:00+00:00By Steve Lee
MD5: The evolution of the EU Medical Device Regulation
2025-11-18T10:06:00+00:00By Célia Cruz
HM4: Revision of the EU Variation Regulation – Continuing innovation in lifecycle management
2025-11-18T09:55:00+00:00By Jessica Roe
HM3: Applying Artificial Intelligence in real life
2025-11-18T09:44:00+00:00By Natasha Bankowski
HM2: Fireside chat
2025-11-18T09:44:00+00:00By Cristina Dragan

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