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Dr. Oskar Köhler

Auditor and Assessor of Technical Documentation, DQS

My name is Oskar Köhler, and I have a PhD in Chemistry from Johannes Gutenberg University in Mainz. With several years of experience in the dental industry as Head of Development, I have been deeply involved in working with medical devices, including the application of 3D printing, as well as in the implementation of regulatory requirements. I joined DQS MED last December. Currently, I serve as an Auditor and Assessor of Technical Documentation, and I am on track to become a Certification Decision Maker in accordance with ISO 9001, ISO 13485, MDD, MDR, and MDSAP.


Session:

Situation with Notified Bodies

Location Darwin room Start / end time 3:00 pm to 4:00 pm

Five Notified Bodies will be represented during this session. They are all designated under MDR and for a few also under the IVDR.

Through a panel discussion, we will tackle current challenges both for the manufacturers and for them, in an interactive manner where the audience can also ask questions.

This session will also be the opportunity to get their feedback on submissions and areas of improvements in order to ensure a smoother review process.