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.

Resources

Healthcare worker holding marker on MDR graph

August 8, 2022

New Proposed FDA Medical Device Quality Control Regulations

New Proposed FDA Medical Device Quality Control Regulations and What It Means for You Earlier this year, the U.S. Food and Drug Administration (FDA), the regulatory body that oversees medical...
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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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active drug delivery system

September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
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