Based especially on my former job as Deputy Technical Director of the formerly Notified Body ECM, 0481, I perform certification and surveillance audits for TÜV
Nord (0044) and ECM strictly separated from my consulting work. In order to grant independence I only perform these audits for products for which I did not advise any
manufacturer during the last 3 years, though. Correspondingly, I have audited according to
Besides, I have been accepted by TÜV Nord as auditor for
- Regulation (EU) 2017/745 (MDR).
Furthermore, I am helping medical device manufacturers by performing internal audits. Thus, I could support you if need a qualified independent internal auditor.