RQM+ Live! #56 — IVDR: A Notified Body Perspective (featuring Marta Carnielli of TÜV SÜD)

Watch this episode of RQM+ Live!

Recorded 9 June, 2022

RQM+ Live! is an interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer your questions live! Every episode is added to our podcast, too.

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RQM+ is bringing together expertise from the world’s largest notified bodies, TÜV SÜD and BSI, to discuss IVDR implementation challenges and lessons learned so far. A lot has happened since October 2020, when notified bodies issued the first IVDR certificates.

In this session we will discuss:

• Notified body feedback in several areas from intended purpose, clinical evidence, and post-market surveillance requirements
• Lessons learned from the IVDR application process
• Expectations and the increased scrutiny mechanism for Class D devices
• Notified body resource challenges and impact on certification timelines
• How to prepare for the future of the IVDR and adapt their transition strategy accordingly.

Our three featured panelists are:

• Marta Carnielli, Pharm D – IVD Technical Director, TÜV SÜD
• Carlos Galamba, MSc – Vice President of IVD Intelligence & Innovation, RQM+
• Heike Möhlig-Zuttermeister​, Ph.D. – Vice President of IVD Intelligence & Innovation, RQM+

More about our SPECIAL guest

Marta Carnielli, Pharm D
IVD Technical Director, TÜV SÜD

Marta Carnielli works for TUV SUD as IVD Technical Director; in this role, she is responsible to gather and distribute regulatory information in the IVD field, represent TÜV SÜD in relevant regulatory committees and conferences and support management and technical experts with the interpretation of regulatory requirements. She is the Co-Chair of the IVD Notified Bodies Working Group Prior to joining TÜV SÜD, Marta worked for Ortho Clinical Diagnostics where she held various roles of increasing responsibility within Customer Technical Support and the Quality, Regulatory and Compliance department. In her most recent role she was Senior Manager, QRC EMEA; in this role she was responsible for quality, regulatory and compliance activities related to the commercial business in Europe, Russia, CIS, Africa and Middle East.