ISO TR 80002-2:2017

Medical device software – Part 2: Validation of software for medical device quality systems

ISO/TR 80002-2:2017(E) 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.