medical-device-software-compliance
From the author
Reason about SaMD (Software as a Medical Device) regulatory compliance for FDA, EU MDR, and global submissions. Use when the user asks about IEC 62304 safety classification, ISO 14971 risk management, 21 CFR 820/QMSR quality system requirements, Design History File structure, 510(k)/De Novo/PMA pathway selection, SOUP/OTS assessment, verification and validation planning, cybersecurity for medical devices, PCCP for AI/ML devices, design reviews, traceability matrices, or post-market surveillance. Triggers include "SaMD", "medical device software", "IEC 62304", "ISO 14971", "ISO 13485", "21 CFR 820", "QMSR", "510(k)", "De Novo", "PMA", "design history file", "DHF", "software safety classification", "SOUP list", "risk management", "hazard analysis", "design review", "V&V protocol", "FDA submission", "EU MDR", "clinical evaluation", "PCCP", "predetermined change control", "GMLP", "cybersecurity premarket", "Part 11", "design controls", "design inputs", "design outputs", "traceability matrix", "post-market surveil
Install
npx skills add awslabs/hcls-agent-skills --skill medical-device-software-compliance -a claude-code
Installs to .claude/skills/medical-device-software-compliance/ · Each command fetches the skill straight from GitHub with the open skills CLI.
Byte-identical to the scanned commit, with the repository’s licence and a SOURCE.txt.
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