- Essays··8 min read
The Inventory You Do Not Have When the Auditor Asks for It
From 2 August 2026, the European Commission's AI Office, together with national authorities, began enforcing the Artificial Intelligence Act. Five days later, Henna Virkkunen confirmed the first formal enforcement step: "our AI Office has formally sent requests for information to a number of providers of general-purpose AI models", reportedly including OpenAI, Anthropic, and Google. …
inventoryyounothaveRead - Essays··8 min read
When the Inspector Asks Why
The FDA's new medical device inspection protocol went live on 2 February 2026. The Quality Management System Regulation (QMSR) replaced the decades-old Quality System Regulation and incorporated ISO 13485:2016. The agency promised new guidance. It arrived on 30 January 2026, just three days before the QMSR became effective.
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