Alcance
ISO/TR 80002-2:2017 applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.ISO/TR 80002-2:2017 applies to- software used in the quality management system,- software used in production and service provision, and- software used for the monitoring and measurement of requirements.It does not apply to- software used as a component, part or accessory of a medical device, or- software that is itself a medical device.