ISO/TR 80002-2:2017Published

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

Logiciels de dispositifs médicaux — Partie 2: Validation des logiciels pour les systèmes de qualité des dispositifs médicaux

Abstract / scope

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.