You have a new idea that you need to get off the ground, quickly
You want to update an old design using the latest technologies
We Can Help
Wherever you are in your medical device development process, we’ll help you take your project to the finish line. Over the past three decades, we’ve worked on dozens of systems like yours. We know the roadblocks and how to circumvent them to accelerate time-to-market.
Having an experienced team ready to help your project can mean the difference between the design and development of a medical device that is delivered quickly, cost-effectively, and in compliance with regulatory standards and one that eats up time, resources, and budget.
What Makes Us Different?
Elite team of experts: Our team is entirely in-house; we do not outsource to contractors. With extensive experience in medical device design and production, our team of experts has successfully completed a myriad of medical device projects, on-time and on-budget.
Regulatory expertise: We offer unparalleled regulatory strategy expertise that will help you achieve faster regulatory approval
Systems and tools: Our Quality Systems (QS) are well established and meet FDA and CE mark standards, and our top-end tools are set up and ready to go to support your entire project lifecycle.
U.S.-based: We are 100% U.S.-based, which means fewer time-zone communication constraints
Flexible solutions: We can accelerate your project using off-the-shelf components to build a unique design tailored to your needs—or we can build a custom system from scratch. Regardless of the design you choose, your design is your intellectual property and for your use only.
We’ll listen to you, understand your challenges, and design a plan that will quickly and efficiently solve your problems. With a seasoned team of experts, industry-leading tools, and proven processes already in place, we can accelerate your project, cut costs, and get you to market faster.
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.
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....