Can I read Reporting Design and Quality Changes on EtoBox?
Reporting Design and Quality Changes by direzionetecnica is a document available to read on EtoBox.
What is Reporting Design and Quality Changes about?
The document outlines the requirements for manufacturers of medical devices to report substantial changes to their quality systems, product range, and device designs to Notified Bodies as per the relevant Council Directives. It emphasizes the need for manufacturers to categorize and document changes, providing specific examples of what constitutes a substantial change. The document also details the assessment process by Notified Bodies and the necessary actions following the reporting of such changes.
- Author
- direzionetecnica
- Language
- EN