Our Story

At Sterling PLM, we solve engineering management problems.

Our story starts with Sterling Medical Devices, an engineering firm that provides product, software, system and electro-mechanical development solutions for medical device manufacturers. Although we’d been designing and developing complex medical devices for customers for years, we continued to face recurring engineering management challenges that warranted more streamlined protocols and better tools for a smoother, more efficient overall process.

As we set out to address our own pain points within Sterling Medical Devices, we soon realized we were not alone in our plight; many engineering companies in the broader market were also struggling with inefficient engineering management processes. With that, Sterling PLM was born.

Today, we help engineering companies across the globe implement proven processes that govern the design and development of their engineered products, while leveraging software that tracks processes with greater visibility across the enterprise.

Our team has decades of combined experience consulting in highly regulated industries for a variety of manufacturers—from small start-ups to large global organizations—and we’ve spent years cultivating unique skills and concentrated expertise in the business of engineering. We specialize in Polarion® ALM™, a browser-based regulatory-compliant software program that helps customers track the project artifacts that they care about—across the entire project lifecycle.

We know our customers’ pain because we’ve lived our customers’ pain. The problems we’ve had to address internally are the problems we now solve for our customers as we help them work more efficiently to unlock their potential.

Resources

hand tests medical device

April 27, 2021

Smart, Cost-effective Medical Device Testing

Your medical device is designed to help patients improve their quality of life—from treating minor illnesses to saving lives. The sooner you get your device on the market, the better for everybody....
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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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