Nandini Murthy

Biography

 Ms. Murthy has over 20 years of work experience in regulatory affairs, clinical and quality assurance functions with multiple device specialties. Ms. Murthy has worked with clients in industry and academia, on novel diagnostic and therapeutic products, including cardiovascular, neurological, radiological, imaging, urological and oncology devices. Ms. Murthy has developed regulatory strategy, represented clients at FDA meetings and authored FDA submissions. She has experience with product approvals for EU (CE Mark), Japan and Canada. In addition to her core expertise in regulatory affairs, Ms. Murthy has designed and executed clinical trials, and established quality systems to ISO 13485 and FDA Quality System requirements. This complementary work experience enables Ms. Murthy to provide the kind of comprehensive regulatory support crucial to novel, early stage ventures, aligning the engineering and clinical support documentation with overall regulatory strategy. Prior to consulting, Ms. Murthy held senior management positions at InfraReDx, Cyberkinetics Neurotechnology Systems, Thermo Cardiosystems and Hologic. Ms. Murthy holds a M.S. from UMass-Boston.  

Research Interest

clinical and quality assurance