Medical Devices & Scientific Instrumentation

Go to Sparton Medical Systems Website

The medical device electronics market has specialized needs, specifically in the design and manufacturing process, to assure product reliability and safety.

With new and rigid regulations, Sparton implemented Sparton Medical Systems (SMS). SMS is a group within Sparton that specializes in systems and procedures targeted to the requirements of medical original equipment manufacturing (OEM) companies.

In a tightly regulated industry, success depends upon processes and controls. A necessary component for SMS to be competitive in the medical device market is adherence to FDA regulations. ISO 13485, a quality standard specific to medical devices, provides industry recognized guidelines for Sparton to meet the stringent FDA design and manufacturing requirements. Sparton has four facilities that are ISO 13485 certified: Strongsville, Ohio; Brooksville, Florida; DeLeon Springs, Florida; Jackson, Michigan; and London, Ontario, Canada.

SMS revenues result from both new and existing customers, with a focus on engaging the customer in the very early stages of the product development cycle. The ability to work with customers during the product maturation process enables SMS to be well-positioned to participate in the long-term manufacturing of the product, as well as the redesign of next generation products.

As the medical device market matures, Sparton will continue to evolve with the latest systems and processes differentiating itself from its competitors. Future efforts are being considered to obtain ISO 13485 certification at other Sparton facilities, and possibly the acquisition of a medical product company or technology to complement SMS services.