Description
This document is a Standard Operating Procedure (SOP) Word Template for Technical Documentation according to the IVDR (Regulation (EU) 2017/746).
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)
- Compliant with ISO 13485:2016 and regulation (EU) 2017/746) (IVDR)
8 pages
Template version: 1.0
Table of Content
1. Purpose
2. Scope
3. References
3.1. Parent procedure(s)
3.2. Related procedure(s)
3.3 External Reference(s)
4. Acronyms & Definitions
5. Responsibilities
6. Description of the Procedure
6.1. Legal Basis
6.2. Content and Structure of Technical Documentation for IVDs
6.3. Compilation of Technical Documentation
6.4. Documentation of Technical Documentation Completeness
6.5. Maintenance of Technical Documentation
7. Records
8. Annexes
Sample:
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