Artificial Intelligence (AI) and Medical Device Software Regulation Guidance Officially Published
Australia, 5 February 2026 — The Australian Therapeutic Goods Administration (TGA) has formally updated its regulatory guidance for medical devices that utilise Artificial Intelligence (AI) and Machine Learning (ML). This update strengthens the Artificial Intelligence Medical Device Software Regulation framework by clarifying when software qualifies as an Artificial Intelligence Medical Device and outlining the regulatory […]
Medical Device Single Audit Program 2026 Update
United States, 09 Feb, 2026 — MDSAP The Medical Device Single Audit Program (MDSAP) remains the most efficient pathway for medical device manufacturers to satisfy the Quality Management System (QMS) requirements of multiple regulatory jurisdictions through a single, comprehensive audit. As of February 2, 2026, the program has reached a critical milestone with the full […]