What is ISO 13485 Certification? ISO 13485 is a certification that sets forth the standard of medical devices. Safety and quality assurance is important, especially in the case of medical equipment. To that end, prove that your medical devices fall to the right standards with ISO 13485 certification. https://operonstrategist.com/services/turnkey-project/quality-management-system/is... https://operonstrategist.com/services/turnkey-project/quality-management-system/iso-13485/?utm_source=google&utm_medium=offpage&utm_campaign=offpage9&utm_id=11