Over 15 years of experience designing, developing and testing the medical devices of the future.

Sterling Medical Devices specializes in medical device design, development, testing, and software development. Sterling has over 15 years of experience working with Doctors, startups, medical device companies and providing solutions for healthcare companies that need to scale up quickly to bring medical device software, hardware, and mobile medical device apps to market by successfully navigating the FDA and CE approval process. We constantly invest in the most state-of-the-art technology so our clients don’t have to. Having the most advanced technology in the medical device industry allows our engineers to work efficiently saving our clients time and money.
Our team of over 50 engineers is highly educated, highly trained and totally focused on the needs of our clients. Unlike some of our competitors, we do not have a stake in the manufacturing revenue stream, so we don’t reuse work that is not optimized for the product simply to move more quickly to the manufacturing phase. We design our clients’ products with a focus on the user needs and requirements, while making smart design choices based on our extensive and diverse product development experience.

Wherever you are in your medical device development lifecycle, Sterling Medical Devices can help.

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5 Biggest Mistakes by Medical Device Startups

How can medical device startups avoid costly mistakes when navigating the FDA submission process to successfully bring their idea to market?

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Developing Mobile Apps for Mobile Medical Devices

How is mobile technology revolutionizing the medical device industry?

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Implementing Agile Project Management Saves Money

What does Agile Project Management mean for the medical device industry?

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Sterling Capabilities

Medical device design and development services include all medical device types, ranging from software-only systems to those requiring electronic and mechanical subsystems.

Custom design & development
for your medical device

  • Medical device design
  • Medical device development
  • Medical device consulting
  • Software and electronics experts
  • Smartphone application experts
  • Custom and off-the-shelf hardware design experts
  • Software unit testing with static analysis
  • Hardware characterization

Get regulatory approval for your medical
device and trust in our quality system

  • Medical mobile apps using IOS (Apple) and Android (Google) software
  • Quality systems
  • ISO Certification: come into an audit – Sterling Medical Devices is registered and compliant including ISO 14971, IEC 62304, IEC 60601

Full testing capabilities for your medical
device software & hardware needs

  • Cost-effective, timely medical device testing
  • System verification and validation
  • Risk planning and hazard identification
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Thought Leadership

Follow Sterling Medical Devices through social media to hear Dan Sterling’s industry ideas, links to relevant articles, and the latest Sterling Thought Leadership.

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The management team at Sterling Medical Devices is a group of highly experienced individuals who bring a wealth of experience and expertise to the company. Thanks to this group, Sterling remains one of the top medical device companies today.

Our depth of experience across a wide array of medical specialties, enables us to move our clients through the development process with insightful agility.

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