Geetha Rao is the FDA Advisor at Cognitive Leap. Geetha holds a Master of Business Management degree from Stanford University Graduate School of Business, and a Ph.D. of Engineering degree from Massachusetts Institute of Technology.

 

Geetha is a strategic advisor to medical device, healthcare, and philanthropic organizations, addressing issues for high-risk technologies, including medical devices, health IT, and connected health systems. Her particular focus on agile quality management and compliance strategy for rapid commercialization. She specializes in guiding companies in achieving lean and cost-effective quality and regulatory compliance.

She also supports clients with regulatory legal problem-solving related to submissions, contractual issues in quality and risk, audit findings, and adverse events. She has established, audited, remediated, and maintained quality system processes and documentation for clients.

She is an internationally recognized expert in risk management and supports international regulation and policy bodies, and standards development organizations with establishing standards and guidance documents in quality and risk management. Specifically, she leads standardization efforts for interoperable medical systems. She has addressed numerous industry forums and the press on issues of emerging health technologies and innovation trends for connected medical technologies.