1,400 projects
Over 300 clients

20+ years delivering
device design innovation

About Sterling Medical Devices

At Sterling, we address the whole development process – systems, software, electronics, mechanical, quality, and compliance – and design our clients’ products with a focus on the needs and requirements of the user, while also making smart design choices that are based on our extensive and diverse experience in product development.

Founded in 1998, Sterling Medical Devices, specializes in the product design and engineering of medical devices for the healthcare industry.  Dedicated to resolving our clients’ medical device design and engineering challenges, we address the whole development process, including product design and human factors, systems, software, electronics, mechanical, quality and compliance.  We utilize the latest tools and technology to streamline the engineering process to speed regulatory approval of Class I, II and III devices.  To date, the company has spearheaded the production of over 1,100 projects for more than 300 clients.

Contact Us

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

Resources

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....
Read More >
View More Case Studies

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
medical device regulation compliancemedical device regulation compliance

Common Medical Device Regulatory Compliance Roadblocks

The medical device industry is heavily regulated by the FDA, specifically, the Center for Devices...

October 22, 2021

Read More >
See All Blogs

Check back soon for upcoming events

    Sign up for regular updates and resources