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Your engineering partner for medical
device development.

Medical Device Development

Partner with a highly-experienced, focused, and flexible group of experts who will help see your medical device project through to completion the right way.

  • Experience in System and Sub-System Development
  • Industry knowledge of medical device engineering
  • Equipped to handle electro-mechanical and software development
  • Proven track record of FDA/CE approvals
  • Multiple capabilities in prototyping and other design processes

Our team of medical device engineers are ready to help at any point in your development lifecycle. By giving proper attention to clinical, regulatory, and engineering constraints, we make sure that the overall system and subsystem requirements necessary for FDA/CE approvals are met.

Sterling Medical Devices is ISO 13485 certified and we work with medical device companies throughout the entire software development lifecycle using state-of-the-art tools and equipment. Our team will help you to align your medical device software development efforts with FDA expectations and gain faster regulatory approvals.

 
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Smart, cost-effective medical device development with Sterling

Every process of the medical device lifecycle requires careful attention to risk: from software engineering planning to implementation to testing to final reporting. A rigorous medical device risk management process will ensure project development time and costs stay low. Sterling Medical Devices has over 15 years of experience having worked on over 400 projects. This experience in risk management helps medical devices get through the FDA & CE approval process easier and to market faster.

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Resources

person typing on a keyboard with security graphics overlay

July 23, 2019

Why Cybersecurity is Becoming More Important in the Medical Device Industry

Cybersecurity in the medical device world has evolved from a footnote to a front-page headline. Articles with titles like “Medical Devices are the Next Security Nightmare” (Wired) and “Medical...
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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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