Medical Device Engineering
Whether you are seeking to design a new medical device product or improve an existing device, Sterling’s unique approach to the device engineering process can help.
- Design for implantable devices, external support and monitoring devices, mobile app medical devices, 510K, PMA and CE class I, II, III device
- Critical chain model with a built-in safety buffer for accurate timeline estimates and transparency
- Reverse engineering service allows customers to create prototypes and utilizes prior work for documentation for regulatory approval
- Sterling’s ISO certifications speed up start-up customers’ regulatory approval processes
From small startups, to leading medical device organizations, we have helped several companies bring their medical devices to the market faster while ensuring that the development process is carried out without fault. Contact us to learn more about how we can accelerate and perfect the engineering process for your medical device.
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.
