quality-manager-qms-iso13485

ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.

Source

Creator's repository · alirezarezvani/claude-skills

View on GitHub

Security

Security checks in progress
Results will appear here once audits complete
What this skill can do
Reads your filesConnects to the internetRuns code on your machine
Checked by 3 independent security firms
Does it try to trick the AI?Not yet checkedPending · Gen Agent Trust Hub
Does it sneak in hidden code?Not yet checkedPending · Socket
Does it have known bugs?Not yet checkedPending · Snyk