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.
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.
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.
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