ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
This standard supersedes earlier documents such as EN 46001 and EN 46002, the previously published ISO 13485, and ISO 13488.
The essentials of validation planning, protocol writing, and change management will be explained.
via ESSENTIALS OF VALIDATION – Do You Really Need It? — Compliance4all