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For EMS providers and contract manufacturers, the International Standards Organization (ISO) 13485 Standard provides a considerable number of challenges. They all fall under the main category of quality management systems for medical electronics products. But now there is a new wrinkle associated with ISO 13485; this wrinkle isn’t in the books and is rarely spoken […]

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ISO 13485 is about potential risks involved and mitigating them during and after the building of medical products. It is a specific ISO standard serving as a comprehensive management system for the design and manufacture of medical devices. Like other ISO standards, its focus is on continuous improvement in process and quality systems. Also, a […]

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