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Quality and compliance in the medical device industry: issues and perspectives

Abstract: Hospitals, health-care centers as well as consumers rely ocount on reliable and high-precision medical equipment to deliver the highest quality of medical care. The production of electronic and electromechanical medical devices and equipment is largely handled by contract manufacturers (CM). These CMs specialize in specific areas such as device assembly, or provide full service capabilities including logistics and post-sales service. The strong emphasis on quality in medical device manufacturing imposes stringent demands on the design and validation processes, as well as the packaging and logistics aspects. Furthermore, this industry is strictly FDA-regulated, and regulatory certification and compliance monitoring are critical needs to establishing strong customer and market credibility.