NeVibeCode · 3 items
Skills and MCP tagged “medical-device”
capa-officer skill Runs CAPA investigations for a medical device QMS: root cause analysis, corrective action planning, effectiveness verification. Useful when you are working a nonconformance or an audit finding.
Claude Code
795installs
mdr-745-specialist skill This skill supports EU MDR 2017/745 device classification, technical documentation, clinical evaluation, and post-market surveillance planning.
Claude Code
737installs
fda-qsr-audit-prep skill This skill checks FDA QSR readiness through 6 forcing questions. Use it before an internal audit, an FDA inspection, or a Form 483 response.
Claude Code
17installs
