Sterling aided in the verification to an update of an imaging system. This system is Class II device with a Moderate Level of Concern. The verification protocols covers the desktop application, CCU...
Sterling Medical Devices participated in the development of an image-guided surgery system including optical tracking devices and localization probes. The system helps surgeons obtain an accurate...
Sterling Medical Devices helped redevelop a remote support web application software targeted to address the underlying cause of tinnitus. The original system was written in Flex. The system has a...
Sterling Medical Devices participated in the development of 3D motion characterization turnkey software to record magnetic field data. This customized software tested the capabilities of an implanted...
Sterling Medical Devices participated in the development of a proof-of-concept gynecological scope prototype. During phase 1, Sterling authored a project plan and requirements documentation designed...
Sterling Medical Devices participated in the investigation and remediation of five medical devices with CAPA issues, all made by the same company. In general, CAPA (Corrective and Preventive Action)...
At Sterling, some of the most common questions we get are related to medical device Food and Drug Administration (FDA) approval in the U.S. and the Conformite Europeenne (CE) mark in the European...
Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
Overview Paxman has been pioneering scalp cooling technology for over a quarter of a century. Paxman’s clinically proven cold cap technology has helped over 100,000 cancer patients in more than 60...
Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis. Request Free Analysis