Can I read Certification Process for MDR Annex IX on EtoBox?

Certification Process for MDR Annex IX by George Nabil is a document available to read on EtoBox.

What is Certification Process for MDR Annex IX about?

This document details the certification process for medical devices under Regulation (EU) 2017/745, specifically Annex IX Section 5, outlining each stage of the audit process and necessary documentation for organizations seeking certification. SGS Belgium NV serves as a Notified Body for Class III and IIb devices, and the certification process typically takes 6 to 18 months, depending on the manufacturer

Author

George Nabil

Language

EN