Selecting and preparing the correct premarket submission for your medical device is crucial, saving you time, money, and headaches in the process of getting your product to market. Clearance and approval from the U.S. Food and Drug Administration (FDA) can feel overwhelming. While it can be a timely and complicated process, that’s where Sterling comes in. With our premarket clearance and approval services, we can support your:
Sterling can help.
At Sterling Medical Devices, our medical device regulatory compliance consultants take on the burden to help you meet the required regulatory controls that assure your medical device’s safety and effectiveness—throughout the entire product development life cycle. We have a deep understanding of the many ins and outs of the FDA requirements processes, so you can leave all the details to us. We will manage the entire process, start to finish.
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.
December 20, 2021
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September 26, 2022