With the launch of its new web site and recognizing a shift in customer demands, SterlingTech, Inc. changes its name to Sterling Medical Devices. Driven by its expertise in providing software and electronics development exclusively to the medical device industry, SterlingTech briefly took on the name Sterling Smartware Solutions; however, customers quickly drove the company to provide complete system development and quality consulting services making “Sterling Medical Devices” more appropriate.
Sterling’s founder and President, Dan Sterling, stated “we had always thought we would migrate from a company focused on what makes devices ‘smart’, the software and electronics, to the entire device development, but we never dreamed things would progress this rapidly; our customers simply demanded more, and we are providing it.”
Smartware remains a core focus of the company which is a term that describes a common sense process of placing software on an equal footing with hardware in the development life cycle. Software is increasingly the main differentiator in medical devices, as well as a source of business risk and hazards; addressing these issues early and often helps bring the project in on time and is consistent with the spirit of applicable standards, like IEC 62304.
Founded in 1998, Sterling has steadily grown with key additions to management and technical staff who draw on their medical device industry experience. The company is now approaching 40 employees and is headquartered just outside New York City in Rochelle Park, New Jersey, convenient to three major airports and train transit, and also maintains a presence in Houston, Boston, and Tel Aviv.
Sterling’s expertise in medical device development includes:
• Implanted Devices
• External Therapeutic, Support, and Monitoring Devices
• Class I, II, and III Devices
• 510K, PMA and CE submission
• Adherence to applicable FDA regulations and internationally recognized standards including QSR, ISO 13485, ISO 14971, IEC 62304, and IEC 60601.
Sterling has partnered with clients on more than 200 projects since 1998 to bring remarkable medical devices to market – in the areas of diagnostics, telemedicine, and therapeutics -including implants.