ISO 13485 is an international standard that specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of medical devices. This standard can also be used by international and external parties, including certification bodies, for assessment of the organization's ability to meet customer and regulatory requirements. The quality management system requirements specified in the ISO 13485:2003 standard complements technical requirements for products. The primary purpose of the ISO 13485:2003 standard is to facilitate harmonized medical device regulatory requirements for quality systems. All requirements of the ISO 13485:2003 standard are specific to organizations providing medical devices, regardless of the type or size.
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