ISO TR 80002-2

Description / Abstract: This document 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.

This document 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.