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The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more
A recent standard interpretation letter dated April 29, 2025, addressed whether employers may use software-generated documents in place of the OSHA-required injury and illness recordkeeping forms, specifically Forms 300...more
The European Commission published guidelines that clarify the definition of AI systems under the AI Act, analyzing each component of the definition of AI system, providing examples and specifying which systems should be...more