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What is ISO 13485?



This International Standard 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, and the design, development, and provision of related services.


It can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.


The medical device industry is affected by a complex array of regulatory systems, national and international standards and other requirements. We provide services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.