Somshekhar Umadi has over 19 years of experience in design and development of Class II medical devices, from concept to commercialization. He has managed cross-functional teams and has undertaken product life cycle management. He also has experience in medical regulatory affairs in line with FDA, CE and standards: ISO13485, ISO14971, IEC62304, and IEC60601-1 and is an assessment team member for SCAMPI Class A Appraisal. He has a Bachelors degree in Electronics and Communication Engineering. Patents: Somshekhar has filed two patents in the field of medical devices.