Template – Product Qualification and Classification under the EU IVDR 2017/746 (v.1.0)

$50.00

This document provides an overview on the qualification of the product as a device as well as the risk classification and the rationale for the classification rule(s) applied in accordance with Annex VIII of the In-vitro Diagnostics Regulation (IVDR) (EU) 2017/746.

Description

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:

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