domain-healthcare:medical-device-software

Medical Device Software

When to use

• Classifying software safety class (A, B, or C) under IEC 62304
• Planning documentation requirements for a regulated software development project
• Performing hazard analysis or building a risk management file under ISO 14971
• Structuring design controls for a 510(k), PMA, or De Novo submission
• Implementing change control for released medical device software
• Addressing FDA premarket cybersecurity guidance for a connected device

Core principles

1. Safety class determines everything — get Class A/B/C right first; it drives documentation depth, testing rigor, and regulatory pathway
2. Traceability matrix is not optional — requirements to design to test cases must be linked; FDA will ask for it and gaps are findings
3. Risk control hierarchy is ordered — inherently safe design beats protective measures beats warnings; document why you couldn't go higher
4. Verification is not validation — "built it right" (spec compliance) and "built the right thing" (user need) are separate activities requiring separate evidence
5. SBOM is now a submission requirement — list every component and dependency; FDA expects it as part of premarket cybersecurity documentation

Reference Files

• references/iec62304-lifecycle.md — software safety classification table, 9-step lifecycle processes, required documentation artifacts (SDP, SRS, SAD, SDD, test plans, traceability matrix)
• references/iso14971-risk-design-controls.md — ISO 14971 risk management process, risk control hierarchy, risk acceptability matrix, design inputs/outputs, design review, design verification and validation
• references/vv-fda-cybersecurity.md — V&V definitions, requirements traceability, code coverage by class, static analysis tools, 510(k)/PMA/De Novo pathways, change control classification, FDA cybersecurity guidance, SBOM, coordinated vulnerability disclosure