Sterling Medical Devices & RBC Medical Innovations are combining to create Vantage MedTech! Meet RBC
Contact Us
Close Form

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!

  • This field is for validation purposes and should be left unchanged.

Wherever you are in your product development lifecycle,
Sterling can help.

P: 201-877-5682
F: 201-301-9169

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.

Contact Us
  • This field is for validation purposes and should be left unchanged.

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.

Share this!


Laptop in lab with FDA logo

May 16, 2023

Who Needs a Q-Sub, and When?

So many questions come up when developing a medical device. What is its intended purpose? Who will use it? How will it be used? What do we need to do? Questions surrounding the medical device...
Read More >
View More Blogs

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.
Read More >
View More Videos

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....
Read More >
View More Case Studies

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.
Request Free Analysis