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Tips for a Successful Validation, Current Situation at the Notified Bodies

Marta Carnielli is an experienced leader with a passion for IVD medical devices. She is skilled in IVD Medical Devices, Change Control, Post Market Surveillance, as well as quality assurance and holds a Master’s Degree in Pharmacy from Università degli Studi di Trieste. Supporting TÜV SÜDs management and technical experts with the interpretation of regulatory requirements gives her inside knowledge about the common pit falls in ISO 9001 and ISO13485 standards as well as Regulation EU 2017/746 (IVDR). At regulatory committees and conferences, she represents TÜV SÜD and holds a Co-Chair of the IVD Notified Bodies Coordination Group (NBCG-MED). Since recently, Marta is Head of Certification IVD at TÜV SÜD. This role entails responsibility for the certification process for IVD medical devices as well as ensuring that accreditations, designation, and authorization relevant to IVDs are maintained by TÜV SÜD.