ISO 13485 Quality Management System specialist for medical device companies. Provides QMS implementation, maintenance, process optimization, and compliance expertise. Use for QMS design, documentation control, management review, internal auditing, corrective actions, and ISO 13485 certification activities.
Quick integration into your workflow with minimal setup
Active open-source community with continuous updates
MIT/Apache licensed for commercial and personal use
Customizable and extendable based on your needs
Download or copy the skill file from the source repository
Place the skill file in Claude's skills directory (usually ~/.claude/skills/)。
Restart Claude or run the reload command to load the skill
Tip: Read the documentation and code carefully before first use to understand functionality and permission requirements
All Skills from open-source community, preserving original authors' copyrights
alirezarezvani__claude-skills/ra-qm-team/quality-manager-qms-iso13485/skill.mdProven benefits and measurable impact
Cut problem-solving time by finding insights that eliminate entire problem areas
Multiply team output by focusing work on essential components only
Eliminate redundant features or steps with single validating insight
Perfect for these scenarios
Identify core requirements to eliminate redundant tasks and dependencies
Find key insights to streamline workflows and remove unnecessary steps
Use one decision to eliminate multiple analysis branches or scenarios
Break complex issues into solvable parts by finding unifying principles