ISO 13485 medical device management system standards
 

A false positive or a misdiagnosis based on a faulty test result a can mean a death sentence. Correct diagnosis, treatment recommendations and scientific advancement all depend on the use of precise medical devices. The health and well-being of ourselves and our families requires medical devices to be calibrated and functioning exactly as they should.  ISO 13485:2016 is the latest, and most current version of the quality management system specifically for medical devices. It is used by organizations involved in the medical device industry, including manufacturers, laboratories, hospitals and universities. Companies use this management system standard to meet regulatory requirements, as well as to employ industry best practices. While it remains a stand-alone standard, it aligns with existing quality management systems.