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Hrishikesh Gadagkar, PhD

Sr. Principal
RQM Plus

Hrishikesh (Rishi) Gadagkar is a Sr. Principal at RQM Plus, where he works with medical device manufacturers to successfully achieve regulatory authorizations. Rishi holds a BSc, MSc, and Ph.D. in Electrical Engineering and has over 31 years of experience within the medical device industry. Rishi has worked on a wide variety of diganostic, therapeutic and in-vitro diagnostic devices at large, mid-sized and start-up manufacturing organizations. Rishi has extensive experience securing 510(k), De Novo, and CE Mark authorizations for several electro-mechanical devices with and without software. His extensive experience in software development for medical devices, allows RQM Plus clients to use his guidance to prepare comprehensive SiMD or SaMD submissions with our without machine learning functions. Rishi is also routinely invloved in helping clients evaluate and complete cybersecurity threat assessments, cybersecurity testing, and risk analysis required to secure regulatory authorization. Rishi has authored several scientific publications and has been a co-inventor on multiple patents.

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