This pack contains 19  profesionally presented templates for every document required to pass ISO 13485 MDQMS  external audit certification and will enable you to create a comprehensive Medical Devices Quality Management System that adheres to international standards. Fully formatted, Doc-Control ready brandable spreadsheets, policies and reports. Every document includes version controlled metadata fields.
 
This pack also includes a complete list of all ISO 13485's requirements and clauses.
 
Simply fill out the documents and embed them within your business to create a world-leading ISO 13485 compliant Medical Devices Quality Management System.