Software, AI, cybersecurity

HAS: evaluation principles for Digital Medical Devices (DMD)

[2025-09-10] On September 10, 2025, France’s HAS (Haute Autorité de Santé) published a press release setting out the principles for evaluating Digital Medical Devices (DMDs). This press release, entitled “Dispositifs médicaux numériques : la HAS explicite ses principes d’évaluation” (Digital medical devices: the HAS clarifies its evaluation principles), reviews the

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MHRA: AI Airlock webinar on June 19, 2025

[2025-05-30] The MHRA (Medicines & Healthcare products Regulatory Agency), the competent authority in the UK, announced on May 30, 2025 that it would be holding its next webinar on the “AI Airlock” project. AI Airlock is a “regulatorysandbox” created to meet the new challenges posed by medical device software using

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