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Product Design, Development, and Engineering Support

Erik Hilliard and Matthew Calloway can help you resolve medical device design and development challenges, from concept through completion, addressing the whole development process – systems, software, electronics, mechanical, quality, and compliance.

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Regulatory Support

Jeni Leberknight can help you navigate the murky waters of regulatory requirements and ensure you are complying with the strict regulations mandated across the medical device industry.

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Resources

3d printing of a medical device

January 26, 2022

The role of 3D Printing in the Medical Device Industry

3D printing is a family of processes that creates three-dimensional solid objects from a digital file using computer-aided design (CAD). Also known as additive manufacturing, 3D printing offers...
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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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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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