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Search 21 CFR Part 11 , found 2 results

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Quality Documentation Manager

quality-documentation-manager

alirezarezvani/claude-skills

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.

MedTech Compliance Auditor

fda-medtech-compliance-auditor

sickn33/antigravity-awesome-skills

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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