Medical Device Engineering

Medical Device Engineering

Whether you are seeking to design a new medical device product or improve an existing device, Sterling’s unique approach to the device engineering process can help.

  • Design for implantable devices, external support and monitoring devices, mobile app medical devices, 510K, PMA and CE class I, II, III device
  • Critical chain model with a built-in safety buffer for accurate timeline estimates and transparency
  • Reverse engineering service allows customers to create prototypes and utilizes prior work for documentation for regulatory approval
  • Sterling’s ISO certifications speed up start-up customers’ regulatory approval processes

From small startups, to leading medical device organizations, we have helped several companies bring their medical devices to the market faster while ensuring that the development process is carried out without fault. Contact us to learn more about how we can accelerate and perfect the engineering process for your medical device.

 
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About Sterling Medical Devices

Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.

Resources

doctor pointing to screen with icons

April 30, 2020

Device Manufacturers Face Challenges to Balance Opportunity and Risk

With an increased focus on technology advancement and product development, medical device manufacturers are beginning to improve their devices and seize new opportunities. However, this comes with an...
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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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Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
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