FDA medical device software certification document generation guide. Based on EN 62304, EN ISO 14971, and ISO/TR 24971 standards, helps generate 13 required regulatory documents (Documentation Level Evaluation, Software Risk Management Plan, Hazard Analysis, SRS, SDS, V&V testing documents, Risk Management File, etc.). Use this skill whenever the user mentions FDA/CE/MDR certification, software risk management, IEC 62304, ISO 14971, hazard analysis, software verification and validation (V&V), medical device software submissions, or asks about any regulatory standard requirements. Standard clauses are built into the references/ directory and can be referenced directly without any external connection.
2026-03-09