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National regulations often require ISO 13485 as part of the approval process for medical devices. Legal market access for products is essential for medical device manufacturers. As a quality management system standard, it is not product specific, but covers processes relevant to the production of medical devices and related services. ISO 13485 provides a practical foundation for manufacturers to address regulations and responsibilities as well as demonstrating their commitment to safety and quality. A certified organization proves its ability to provide medical devices and that related services consistently meet customer and applicable regulatory requirements. It is designed and intended for organizations involved in related to design and development, production, installation, servicing and sales of medical devices. ISO 13485 is the internationally recognized industry-specific standard for quality management systems.
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