Athena Compliance Centre - Quality Management System (QMS) Details

Domain

Summary

 The QMS identifies the documentation and requirements identified in ISO13485.

Overview

This section provides a framework of the processes and procedures which need to be implemented to demonstrate your business is meeting the requirements set out in the Quality Management System of ISO13485.

Detailed Description

<p>Medical devices - Quality Management Systems - Requirements for regulatory purposes ISO 13485:2016</p>

Reference/Support Links

Governing bodies/Certifiers/Legislation Links

<p>ISO 13485:2016</p>