Skills and MCP tagged “iso-13485”

ra-qm-skills Alireza Rezvani skill Routes regulatory and quality management queries to 15 specialised skills in the ra-qm-team bundle. Useful when a compliance task does not immediately match a single standard. Claude Code 1,653installs quality-documentation-manager Alireza Rezvani skill This skill manages document control workflows for medical device QMS under ISO 13485 and 21 CFR Part 11. It helps set up numbering conventions, approval flows, and change control. Claude Code 803installs qms-audit-expert Alireza Rezvani skill Guides ISO 13485 internal audits for medical device quality management systems. Useful when planning audit schedules, evaluating nonconformities, and preparing for external inspections. Claude Code 747installs fda-qsr-audit-prep Alireza Rezvani 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