Iso 13485 Certification

This is a comprehensive documentation assistant for medical device manufacturers preparing for ISO 13485:2016 certification. It walks you through gap analysis of existing QMS docs, generates templates for all 31 required procedures, and prioritizes what to tackle first (Quality Manual and CAPA before the specialized stuff). The gap analyzer script is practical, it scans your existing documentation directory and tells you exactly what's missing. Includes clause-by-clause breakdowns of the standard and fills-in-the-blanks templates that handle the boilerplate. Honestly most useful if you're starting certification from scratch or doing a major documentation overhaul, since it's built around the full workflow from assessment to audit prep.

Install to Claude Code

npx -y skills add k-dense-ai/scientific-agent-skills --skill iso-13485-certification --agent claude-code