ISO 13485:2016 is a standard for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. The primary purpose of the ISO 13485 standard is the Harmonization of the Medical Device regulatory requirements for Quality Management Systems. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. This standard is relevant to suppliers or external parties that provide product, including quality management system-related services to such medical organizations.
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