PD ISO/TR 80002-2:2017 - Page 2

Medical device software. Validation of software for medical device quality systems | Status: Current

1 Scope 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.