Instructor

Pooja Kartik LinkedIn

"Approximately 70 percent of software-related recalls are due to software design issues that can be mitigated by using risk-based software development lifecycle processes."

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POOJA KARTIK, BS, teaches at AAMI and is vice president of Quality and Regulatory at Triple Ring Technologies. She started her medical devices career working in the embedded software in the Medronic Quality, Regulatory, and Program Management offices in 2001. Since then, she has held both strategic and tactical roles in pre-market and post-market quality, medical device software development life cycle, risk management, GxP software, computer systems validations, software engineering, software quality engineering, and regulatory compliance. She is a recipient of the AAMI 2008 Technical Contributor Award for IEC 62304. Pooja earned a Bachelor of Science degree in Computer Science from the University of Akron and completed an executive education in Digital Transformation from Harvard Medical School. She is passionate about innovation, patient safety, and solving hard problems and is currently pursuing Executive Education in Business Management LEAD Program at Stanford University Graduate School of Business.

Associated Program(s)

Medical Device Quality and Design

Validating Software for Medical Devices and Emerging Technologies