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FDA MedTech Compliance Auditor

Audit medical device software against 21 CFR Part 820, IEC 62304, and ISO 13485 with severity-ranked findings and corrective actions.

Install

/plugin install fda-medtech-compliance-auditor@sickn33

Requires Claude Code CLI.

Use cases

MedTech teams review Design History Files, validation protocols, and CAPAs against FDA regulations to pass inspections.

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Stats

Installs0
GitHub Stars27.2k
Forks4595
LicenseMIT License
UpdatedMar 25, 2026

Creator

S

sickn33

@sickn33

View on GitHub