Challenges with the conformity assessment of Class D devices with Roche Diagnostics​​​​​​​

In this Deep Dive session, you will meet our experts Dr Laura Scrivano and Melanie Ermlich. They will discuss with Dr Stefan Scheib the challenges manufacturers and Notified Bodies face during the conformity assessment of Class D devices and how they are currently managed. External speaker: Dr Stefan Scheib, Global Head of Regulatory Affairs, Roche Diagnostics. An regulatory affairs professional with more than 25 years of experience in the health care/medical device industry.

Date and time: Thursday, 27 October 2022, 5.00 pm (CEST) / 11.00 am (EDT)

Your speakers: Dr Laura Scrivano, Team Leader IVDR

Melanie Ermlich, Clinical Reviewer IVDR

Dr Stefan Scheib, Roche Diagnostics GmbH

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