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17 Legion Place
Rochelle Park, NJ 07662
United States of America, New Jersey
Phone: 201 227 7569
Sterling Medical Devices is a full-service medical device organization offering software and electronics development and validation services. The firm has developed software and electronics for an array of medical products including implantable devices, and it has experience in external support and monitoring equipment. Our team has worked on Class I, II, and III devices that resulted in successful FDA 510(k)s, PMAs, and CE submissions. We’ve optimized our software process for our clients’ particular goals: lowest cost, fastest turnaround, risk, or a combination. Maintaining flexibility in our working structure, we can integrate within your organization or work independently. We provide support to the entire medical product life cycle from requirements capture to GMP manufacturing support. A common task for us is working with early stage companies to help them get the software they have developed ready for FDA or CE submission. We will review the artifacts that you have and work with you to generate the missing pieces such as design documents, Hazard Analysis, and Verification & Validation reports. We offer a no cost proposal service to analyze your needs and determine the most cost effective solution. For more information visit www.sterlingmedicaldevices.com
Last update of this entry: September 11, 2015
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