ISO 13485 specifies requirements for a quality management system for the design and development, production, installation, and servicing of medical devices, and the design, development, and provision of related services. It can also be used to assess the organization’s ability to meet customer and regulatory requirements. The quality management system requirements specified in ISO 13485 are complementary to technical requirements for products.
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You may view and download our current ISO Certificate via the following link: ISO 13485:2016.