Medical device software development is an ever-evolving field within the medical device industry, and it is growing increasingly complex in design and functionality. This constant growth matches the growing need for enhanced patient care and therapies. Now more than ever before, you need a trusted partner who can guide you through each and every step of your medical device software development process.
Sterling Medical Devices is well equipped to step in at any stage within your development lifecycle to help you develop a safe, effective, and FDA/IEC 62304 compliant medical device product. Here at Sterling, we will work closely with you and your team to understand every aspect of your design, development, and testing needs to help ensure a quality Class I, II, and III medical device product.
A trusted partner like Sterling Medical Devices can help you address your software design challenges and help you streamline the process of having your medical device product reviewed by the FDA. Our team works with you to understand the intended use of your medical device software and all of the requirements that your software must meet in order to be considered a safe, secure, and compliant medical device product.
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.
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