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Carrie Hetrick

Carrie Hetrick

Director of Regulatory and Clinical Affairs

Resource Director of Regulatory and Clinical Affairs Carrie Hetrick has over 20 years of experience in the medical device industry. Ms. Hetrick leads regulatory, clinical, and quality programs at Sterling, helping companies navigate challenges in product development while establishing appropriate clinical, regulatory, and compliance structures during each stage of development. A seasoned subject matter expert in taking new products from R&D to market, she has used her regulatory and clinical expertise to aide in hundreds of successful regulatory submissions and clinical trials in the U.S. and Europe. Ms. Hetrick has led numerous quality management and business process improvement and management measures. She is also experienced in leading early and late-stage cross-functional medical product development programs, directing activities and teams for all phases of design controls, and creating collaborative alliances. She holds a Master of Science in Advanced Biotechnology, Regulatory Science from Johns Hopkins University, a Doctor of Dental Surgery from the University of Colorado Health Science Center School of Dentistry, and a Bachelor of Science in Biology from Pacific Lutheran University. She finds great reward in helping patients through ushering products to market.

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Resources

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February 7, 2019

US FDA Recognizes New Cybersecurity Standard UL 2900-2-1

What Does it Mean for the Medical Device Industry? The current ever-changing landscape of cybersecurity threats and hazards, amongst ransomware campaigns and remote vulnerability cracks, call for...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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September 26, 2022

Sterling Medical Devices Creates Controller to Power Puzzle Medical Devices Inc’s. Groundbreaking New Multi-Pump Mechanical Circulatory Support Device

Overview Puzzle Medical Devices Inc., is a leading medical device company specializing in the development of a minimally invasive multi-pump mechanical circulatory support (MCS) designed to reduce...
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