Wherever you are in your product development lifecycle,
Sterling can help.
Human factors engineering, or medical ergonomics, is the process of evaluating and changing the design of devices to better fit the human body and its cognitive abilities. The U.S. Food and Drug Administration (FDA) considers human factors engineering in device regulation because the safety of medical devices relies on them being used as intended, as well as their reliability. The FDA expects device developers to account for human factors within their processes.
The intent of the human factors process at the FDA is to ensure the development team demonstrates and documents:
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.
August 10, 2021
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September 8, 2020