Claude for Life Sciences Just Made LLM Compliance Urgent. Here's the Framework.
Anthropic's life sciences and healthcare push, from the January 11 Claude for Healthcare launch through the May 14 Gates Foundation partnership, has accelerated LLM adoption in pharma, medical device, biotech, clinical research, and provider operations. The compliance posture has not kept pace. The framework for scoping 21 CFR Part 11, FDA CSA, EU AI Act, IEC 62304, ICH E6(R3), HIPAA, GAMP 5, and Agent Skills governance against specific LLM use cases.
FDA Just Held Its First QMSR Town Hall. Here's What the Enforcement Data Already Tells Us.
132 Form 483 observations across 52 inspections. 89.4% cite ISO 13485:2016 clauses directly. 50% of inspected firms received risk management observations. The first comprehensive analysis of post-QMSR enforcement data from FDA's public databases, combined with intelligence from the April 1, 2026 Town Hall.