Ms. Murthy has over 25 years of work experience in regulatory affairs, clinical and quality assurance functions with multiple device specialties. She has authored numerous, successful FDA submissions including a de novo, a modular PMA, a HDE, original PMAs, several original IDEs, pre-Submissions, PMA and IDE Supplements and 510(k)s for novel products including implantable devices, sensor/monitoring tools and diagnostic devices. She has experience with product approvals for the EU (CE Mark) and Canadian markets. She has led projects with complex submissions, where she has both managed a team and where necessary, written or executed on the various document deliverables in a hands-on manner. Ms. Murthy has a successful track record of on-time execution and FDA approvals. 

In addition to her core expertise in regulatory affairs, Ms. Murthy has designed and executed complex clinical trials and established quality systems to ISO 13485 and FDA Quality System requirements. She has helped early stage and more established larger companies develop their quality systems consistent with their stage of device development. She has experience in developing plans for Quality Systems projects, including tactically prioritizing and directing focus, and updating/communicating plans and status with Management.