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Marco Caproni (he/him/his)

Global Director Software Product Assessment
TUV SUD, Italy

Ing. Marco Caproni holds a MSc in biomedical engineering. He joined TÜV SÜD in 2018 as Product Specialist for active medical devices. His role in TÜV SÜD Product Service GmbH Notified Body is Senior Product Specialist of Software (MDA 0315 and MDS 1009) and AI.
He has 15 years of professional experience in the design and development of medical devices, in the area of software, extracorporeal circulation devices (such as dialysis) and has worked as software- and active medical devices-focused certification lead auditor and technical documentation assessor.
As Lead Auditor, Project Handler and Technical Documentation assessor, Marco is actively driving conformity assessment activities for active medical devices customers in Italy and internationally. As Senior Product Specialist, Marco is the ultimate responsible for answering technical questions, making decision in case of unclear requirements about MDA0315, MDS 1009 and software in general.
He is now Global Director Software Product Assessment team, head of the department in charge of MDR/IVDR assessments on software devices and components, including Cybersecurity and AI.

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