Word Template referencing all documents that must be included in the Technical Documentation according to the IVDR (Regulation (EU) 2017/746). This document can be used as a Table of Content to link easily the different sections of the Technical Documentation to the product documentation.
- 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)
- Compliant with ISO 13485:2016 and regulation (EU) 2017/746) (IVDR)
Template version: 1.0