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21 CFR Part 11
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Quality Documentation Manager
quality-documentation-manager
alirezarezvani/claude-skills
229
Manages medical device quality system documents, covering numbering, version control, change workflows, approvals, and 21 CFR Part 11 compliance to keep regulated QMS records auditable and current.
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MedTech Compliance Auditor
fda-medtech-compliance-auditor
sickn33/antigravity-awesome-skills
203
Turns your assistant into a MedTech Compliance Auditor that reviews SaMD and medical device files against 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, and Part 11, surfacing findings with citations and remediation steps.
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