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About the Author

With a Master of Science in Biomedical Engineering, Enrico Perfler boasts 20 years of professional experience specializing in medical device technology. His profound knowledge and innovative approach have significantly shaped the landscape of this field. In 2014, Enrico founded 1MED SA, an innovative international company that provides regulatory support, digital solutions, and comprehensive CRO services to the medical device and pharmaceutical industry, with a particular emphasis on IVD and medical products. Under his leadership, 1MED SA has successfully overseen the development and regulatory approval of over 500 medical devices in Europe, solidifying his status as a prominent figure in the MedTech sector. Beyond his remarkable entrepreneurial achievements, Enrico serves as a contract professor of "Regulatory Affairs" at the Faculty of Engineering, University of Pavia. His expertise is further highlighted by his participation in the ISO/TC 194 technical committee for the biological evaluation of medical devices, and in national esteemed standardization groups, including UNI and ABHI. This involvement not only showcases his commitment to advancing industry standards but also underlines his influential role in shaping the future of medical device regulation and safety.

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