You need this course if...
- You are responsible for managing an ISO 13485:2003/EN ISO 13485:2012 based Quality Management System
- You own or manage Quality Management System processes in your organization
- You are an Internal Auditor of an ISO 13485:2003 / EN ISO 13485:2012 based Quality Management System
- You require an understanding of the extent and nature of the changes in this revision of ISO 13485:2016 in order to facilitate a smooth transition and raise awareness of the changes and the preparation needed within your organization.