aminalam/meddev-agent-skills

v1.0.0MIT

Medical device software skills for lifecycle planning, risk management, firmware, security, testing, and traceability.

meddev-fda-820-design-controls

Map 21 CFR Part 820 Subpart C — Design Controls to software lifecycle work: design planning, inputs, outputs, review, verification, validation, transfer, and DHF/DMR links, including how software validation (intended use / risk controls) complements verification (requirements and specs). Includes a concise ISO 13485:2016 slice where it overlaps QMS expectations for design and risk (interpretation; align with your notified-body MDSAP scope for EU). Use when working on fda 820 design controls in medical device software.

Version: 1.0.0
License: MIT

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skills/meddev-fda-820-design-controls/SKILL.md

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