Medical Device Algorithm Development
Partner with a highly-experienced, focused, and flexible group of experts who will help see your medical device algorithm development project through to completion the right way.
- Experience with 510K, PMA and CE Class I, II and III devices
- Get products to market quickly and cost efficiently
- Development through the software design process
- Team of experts with experience in algorithm development
While innovation in medical device software design gives rise to new medical device designs and breakthroughs, it also creates new concerns about safety and effectiveness. According to the FDA, most medical device recalls can be attributed to software design failures. And when software as a medical device fails, patients are at risk. What’s more, medical device security is a growing concern.
A trusted partner like Sterling Medical Devices can help you address your software design challenges and help you streamline the process of having your medical device product reviewed by the FDA. We work with you to understand the intended use and requirements of your medical device software design to establish the foundation for safe, secure, and compliant medical device products.
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.
