[1.0.0] - 2026-06-08
Initial release of the Healthcare FDA SaMD Knowledge Pack. Covers SaMD regulatory framework, IEC 62304 software lifecycle (reference by clause number), cybersecurity requirements per FDA 2023 guidance, design controls (21 CFR Part 820), post-market surveillance, clinical validation, AI/ML algorithm change protocols, and SBOM requirements. Content authored by Claude (Option A). Status: generated - pending human expert review before publication.