Be successful at your MDR and IVDR audit with Martin Witte
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 Martin Witte?
Martin Witte is Senior Director Strategic Business Development at TÜV SÜD and responsible for the focus topics Active Medical Implants, Cardiovascular, Orthopedic, and Functional Safety/Software.
Prior to his current role, Martin worked as a Lead Auditor, Product Specialist in TÜV SÜD from 2014 on, and took over business development activities with his role as the head of the Active Implants business in 2016. Prior to his roles in TÜV SÜD, Martin was a Regulatory Affairs Manager at BIOTRONIK, Berlin focusing on heart rhythm management devices and on MRI safety of such devices.
His background is Biomedical Engineering which he studied in Hamburg.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.
After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
- Martin Witte LinkedIn: https://www.linkedin.com/in/martin-r-witte/
- TÜV SÜD Notified Body page: https://www.tuvsud.com/en
- Audit preparation: https://easymedicaldevice.com/medical-device-audit/
- MDCG 2020-14 guidance: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_2020-14-guidance-mdsap_en.pdf
- MDCG 2020-4 guidance: https://ec.europa.eu/docsroom/documents/40705/attachments/1/translations/en/renditions/native
- TÜV SÜD application form: https://bit.ly/3i2Ahnl
- MDSAP audit preparation: https://easymedicaldevice.com/mdsap/
- Episode 77 – Notified Body situation: https://podcast.easymedicaldevice.com/77/
- TOPRA Symposium 2020: https://www.topra.org/sym2019