From domain-healthcare
Guides medical device software development per IEC 62304 lifecycle, ISO 14971 risk management, design controls, V&V, FDA submissions, change control, and cybersecurity.
How this skill is triggered — by the user, by Claude, or both
Slash command
/domain-healthcare:medical-device-softwareThis skill is limited to the following tools:
The summary Claude sees in its skill listing — used to decide when to auto-load this skill
- Classifying software safety class (A, B, or C) under IEC 62304
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 validationreferences/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 disclosurenpx claudepluginhub rnavarych/alpha-engineer --plugin domain-healthcareAudits medical device software (SaMD) compliance against IEC 62304, 21 CFR Part 820, ISO 13485, and ISO 14971. Reviews DHFs, CAPAs, validation protocols, and risk files with severity-graded findings and regulatory citations.
Determines FDA premarket pathways (510k, De Novo, PMA) for AI/ML-enabled medical devices based on intended use and predicate landscape.
Guides gap analysis, document creation, and compliance checks for ISO 13485:2016 medical device QMS certification. Helps prepare Quality Manuals, SOPs, and Medical Device Files.