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.

Resources

March 29, 2021

What Is Polarion?

Learn more about our tool that streamlines product development in a compliance-based...
Watch Now >
View More Videos

November 13, 2024

Vantage ALM announces new branding as Vantage ALM

MOONACHE, N.J. and LENEXA, Kan., November 13, 2024 – Vantage ALM, a Vantage MedTech Company has announced it is rebranding as Vantage ALM. Vantage ALM helps engineering companies across the globe...
Read More >
View More Articles

April 19, 2023

Requirements Management and Cybersecurity Webinar

Do you struggle with managing requirements for your products? Are you concerned about cybersecurity and the potential impact of software...
Read More >
View More Download Tools

Sign up for regular updates and resources

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