Cybersecurity

Cybersecurity

As our devices become more connected, and the risk of network breaches increases, the FDA has taken a strong interest in guiding manufacturers in a proactive manner to take stringent cybersecurity measures for their medical devices. Sterling has successfully guided over 400 client medical device projects through the FDA approval process for cybersecurity initiatives.

  • Expertise in the intersection of mobile devices and portable medical devices
  • Experience with current FDA, EU, and other government regulations
  • Agile project management to aid clients in eliminating threats to cybersecurity

The FDA sees the mitigation of cybersecurity threats as a shared responsibility of healthcare facilities, patients, providers, and device manufacturers. Our experienced and innovative team of medical device engineers is here to help you design, test, validate, and advise on medical devices, and navigate the FDA submission process with our clients.

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About Sterling Medical Devices 

Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.

Resources

healight

November 5, 2020

Healight: The Moonshot Not Yet Heard Round the World

Imagine a technology so innovative and groundbreaking in its potential impact that its sponsor is calling it “a moonshot” and “an opportunity so big you could build an entire company around...
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Person working on medical device

October 29, 2020

Sterling Medical Devices Unveils Innovation Growth

MOONACHIE, NJ — Sterling Medical Devices, a leader in custom electro-mechanical and software solutions for the medical device industry, is pleased to announce the renovation of their Regulatory Affairs Department that will now focus on providing strategic guidance and collaboration...
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design-medical-device-sharp

September 11, 2020

Keys to Success in the Digital Health/Mobile Medical Device Market: Experienced Partners

Digital health, including mobile medical devices and applications, is offering patients, providers, health systems, and insurance carriers’ real-world opportunities to improve medical outcomes and enhance the efficiency of healthcare around the world....
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Need help with your medical device?

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FDA/CE approval with a free custom project analysis.
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