GSO ISO/TR 80002-2:2021

ISO/TR 80002-2:2017

Gulf Standard Current Edition · Approved on 01 July 2021

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

GSO ISO/TR 80002-2:2021 Files

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GSO ISO/TR 80002-2:2021 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.