As per ISO definition, the ISO 13485:2003 Standard relates to quality management systems in the field of Medical Devices, including IVD (In Vitro Diagnostic). The standard can be used by an organization for the design, development, production, installation and servicing of medical devices as well as for the design, development and provision of related services.ISO 13485 can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.

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