Template for product qualification and classification under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
Features
- Fully implementable for a paper-based or a electronic Quality Management System (QMS) / Document Management System (DMS)
- Customisable without restrictions (parts highlighted in yellow help you to know where to customise the document)
15 pages
Template version: 1.0
Table of Content
1. Purpose
2. Scope
3. References
3.1. Parent procedure
3.2. Related procedure(s)
3.3. External Reference(s)
4. Acronyms and Definitions
5. Intended Purpose
6. Qualification
7. Classification
8. Applied Conformity Assessment
9. Conclusion
10. Records
11. Annexes
Sample:
