Project Redesign

If your supply chain challenges are too great to overcome, sometimes the best and only option is to redesign your product. For the past 25 years, Sterling Medical Devices has offered industry knowledge and expertise in medical device system development to help you overcome and avoid supply chain issues. From hardware to mobile apps, Sterling has helped companies – ranging from small startups to leading medical device organizations – overcome design challenges and develop innovative medical devices with successful regulatory submissions.

From redesign, to engineering, to testing, and beyond, we’ll work with you during all the medical device development phases. Our team of medical device engineers starts by fully understanding your design challenges. We will maintain open lines of communication and keep you informed every step of the way. We optimize our engineering methodologies to minimize the total duration of the project, maximize your return on investment, and help you meet your regulatory goals.

Resources

FDA-inspection-process

May 24, 2021

How to Prepare for an FDA Inspection

As a medical device manufacturer, you are likely all too aware of the looming threat of an FDA inspection of your quality systems and risk management protocols. While the FDA approval process has...
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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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people developing a product

November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

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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