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Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
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RAPS Focus
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Networking Opportunity
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Ticketed Event
Student Focus
Student Focus

Sarah Panten, Dipl.-Ing.

Co-Founder & Managing Partner / Board Member
avasis solutions GmbH / Medical Device Knowledge Unit e.V.
Hamburg

Sarah has a background in medical technology and has worked in various positions since 2007. Initially, she worked as an international product manager for Olympus Surgical Technologies Europe before entering the QM & RA world as a consultant for Prosystem AG (now NSF) in 2010. With her acquired knowledge and expertise, she joined the established startup iThera Medical in 2014, where she was responsible for the implementation of a QMS according to ISO 13485, the coordination of development and market access activities for the world's first optoacoustic tomography medical device with CE marking. In this position, she introduced digital processes and digital technical documentation from the beginning and recognized the enormous potential for digital solutions in the medical device industry. Based on this experience, she joined the avasis group in 2019 and now focuses on the development and implementation of software solutions for the digitalization of regulatory processes. She initiated and moderated various workshops to discuss regulatory questions and subsequently co-founded the non-profit association Medical Device Knowledge Init (MDKU) e.V. together with other MedTech experts. The organization develops an open source data model for the technical documentation of medical devices in Europe. Sarah is a member and spokesperson of the board. She is leading the DIN SPEC 91509 project, during which results of the MDKU data model development are reviewed by a wide range of industry stakeholders to ensure broad acceptance in the Medtech industry. In addition, she is a trainer for the TÜV SÜD Academy and member of the German "IDiS" (Initiative Digitale Standards) initiative that supports the implementation of the new digital SMART standards format specifically for the medical device industry.

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