Be successful at your MDR and IVDR audit with Martin Witte

Medical Device made Easy Podcast · Sep 7, 2020

If you are preparing for your EU MDR 2017/745 or IVDR 2017/746 audit, then this episode is for you.

I have invited Martin Witte from TÜV SÜD to provide some tips or highlights on what a Notified Body is expecting to see during an audit. Who better than a Notified Body to tell you what you should do.

We will discuss:

Contacting the Notified Body and planning the audit

What is expected to see within your Quality Management System?

How your technical files will be reviewed? – The situation with the Coronavirus and on-site audits

Martin will also be a Speaker at TOPRA Symposium 2020.

Who is…