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Pooja Kartik

Pooja Kartik

Sr. Director Quality & Regulatory
Triple Ring Technologies

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About this Speaker

Pooja has significant Quality and Regulatory Compliance Leadership experience in the healthcare industry. She began her career in medical devices in the Design Software Quality and Reliability department of Medtronic Diabetes Group. Most recently, Pooja was Director of Regulatory Compliance at Intuitive Surgical, and prior to that, was Director of Product Quality Assurance & Compliance at Abbott Diagnostics.

Pooja received her Bachelor’s degree in Computer Science from University of Akron, Ohio, and has earned certificates for Regulatory Affairs Professional for Medical Devices, US and EU from RAPS (Regulatory Affairs Professional Society), ISO 13485:2016 / ISO 9001:2015 Lead Auditor, and EU MDR Lead Auditor. Additionally Pooja is a recipient of the Technical Contributor Award from AAMI International Standards Committee for EN 62304 (Medical Device Software Development) and acted as an alternate voting member for AAMI International Standards Committee.

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