About us

Nandini Murthy, MS, RAC, Principal


Ms. Murthy has over 20 years of work experience in regulatory affairs, clinical and quality assurance functions with multiple device specialties, including cardiology, neurology, radiology and diagnostics. Having served on the Executive team of several companies, she brings a blend of a strategic, solution-oriented mindset along with strong tactical abilities. Much of her experience has been with cutting-edge device and drug-device combination products, with no prior regulatory precedent, and where she has defined the regulatory strategy and plan. Ms. Murthy has a successful track record of on-time execution and FDA approvals. She has authored numerous FDA submissions including original PMAs, original HDE, original IDEs, PMA and IDE Supplements and 510(k)s for novel products.


Ms. Murthy has also designed and executed complex clinical trials including the REMATCH, SPECTACL and BrainGate trials. She has established quality systems to ISO 13485 and FDA Quality System requirements. This complementary work experience helps Ms. Murthy provide comprehensive regulatory support, aligning the engineering and clinical support documentation with overall regulatory strategy.


As a Consultant, Ms. Murthy has worked on projects for clients with novel Class II and Class III diagnostic and therapeutic devices and drug-device combination products, including:


  • Drug delivery device
  • Imaging agents
  • Peripheral stent
  • Ventricular Assist Devices (VADs)
  • Nanotechnology
  • Cardiovascular coronary imaging device
  • Diagnostic displays
  • Non-radiological breast cancer screening device
  • Cervical cancer screening device
  • Transcranial Magnetic Stimulation device
  • Neuroprosthetics
  • IVD cancer monitoring kit
  • ECG and Optical monitoring devices
  • Pediatric blood pumps
  • IVDs
  • Esophageal cancer detection device
  • Air purification device
  • Implantable restorative gel

Ms. Murthy has also functioned as the head of regulatory affairs on a contract basis for early stage ventures. She has provided advice on regulatory matters to academic and research institutions, towards fund raising and grant application activities.


Prior to establishing ENEM Consulting LLC in 2007, Ms. Murthy served as Vice-President, Clinical, Quality and Regulatory Affairs at InfraReDx. She previously served as Vice-President, Regulatory Affairs and Quality Systems at Cyberkinetics Neurotechnology Systems. Ms. Murthy has also held regulatory, clinical and quality management positions at Thermo Cardiosystems (now part of Thoratec), Hologic, Aspect Medical (now part of Covidien) and Toxikon. Her work experience includes mergers and acquisitions support, and a tenure at the USCI Division of C.R. Bard, supporting the company's efforts to address the FDA Consent Decree.


Education Background:


Master of Science. Environmental Science, September 1990. University of Massachusetts, Boston


Bachelor of Science. Chemistry, Environmental Science 1987. Bangalore University, India


Professional Affiliations:


Regulatory Affairs Professional Society (RAPS)


Medical Development Group (MDG)


Certification:


Regulatory Affairs Certified (RAC)


Speaking Engagements:


Speaker, FDA News Quality Congress, Boston, MA


Moderator, Chairperson and Speaker, IDE Workshop, RAPS Annual Device Conference, San Francisco CA


Speaker at ASAIO Annual Conference, IDE Applications Workshop


Speaker at ASQ-NEBDG "Lifecycle of a Medical Device" Workshop


Publications:


Co-author, Chapter 2, Regulatory Agencies and Pathways. "Fundamentals of US Regulatory Affairs", Sixth edition, published by RAPS.