You want to get your product to market as quickly as possible, but to do so, you need to ensure you are complying with the strict regulations mandated across the medical device industry. Failing to do so can put your business—and more importantly, your end-users—at risk. Navigating the murky waters of U.S. Food and Drug Administration (FDA) regulatory requirements, and knowing which ones your device is subject to, can be daunting, even for the most established medical device manufacturers.
Sterling can help.
Before bringing a medical device to market in the United States, it is essential to determine the proper classification and applicable regulatory requirements it must adhere to in order to ensure patient and user safety. With Sterling’s regulatory strategy support, we help you identify and address key FDA requirements for your device including:
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