Getting the classification wrong can have serious consequences for your budget and timeline. It’s important to do your research and work with experts to ensure you’re selecting the right classification for your device. Don’t let incorrect product classification derail your development process and cost you valuable time and resources. Get it right the first time and save yourself the heartache of costly delays.
Sterling can help.
Let us help you get it right. Our team of experts can provide the guidance and support you need to classify your medical device correctly, so you can move ahead with confidence. Your classification will determine the regulatory strategy you need to follow to bring your device to market.
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.
New Proposed FDA Medical Device Quality System Regulations and What It Means for You Earlier this year, the U.S. Food and Drug Administration (FDA), the regulatory body that oversees medical...
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.
Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
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