Determining the correct classification of a medical device is necessary to choose the appropriate U.S. Food and Drug Administration (FDA) regulatory strategy. Failure to do so in the early stages of device development can have dire consequences on your budget and the time it takes to bring the device to market.
Sterling can help.
Medical devices in the U.S. are regulated based on a numeric FDA classification system evaluating the level of risk posed by the product and the level of control needed to ensure adequate safety. These classes are:
For a deeper look at the difference between a Class I and Class II medical device, how to classify a Class III medical device, and other industry insight, please check out our blog.
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.
February 18, 2021
September 8, 2020