What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD]
After few months of MDR, I proposed TÜV SÜD share with us the most common mistakes they find during their audits. And Martin Witte accepted to summarize some of them. So in this episode, you will hear the TOP 3 issues that are discovered so you can be prepared for it. You will see that some of them are obvious and others are more subtle.
- Administrative work
- Clinical evaluation
And Martin will also provide you some advice on how to be prepared for such an audit. He will also answer a bonus question which is: “Can we invite auditors to a restaurant or offer them a gift?” Don’t miss the links below related to what we discussed.
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 in 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 companies 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, podcasts, online courses…
Links from the Video
- Martin Witte LinkedIn Profile: https://www.linkedin.com/in/martin-r-witte/
- TÜV SÜD website: https://www.tuvsud.com/en
- MDCG MDR Codes: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2019_14_mdr_codes_en.pdf
- MDCG IVDR codes: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021-14-guidance-ivdr-codes_en.pdf
- MedBoard: https://www.medboard.com/
- MDCG CEAR: https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_clinical_evaluationtemplate_en.pdf
- CMR Articles: https://www.intertek.com/blog/2020-06-22-mdr/