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ISO/TR 80002-2:2017

ISO/TR 80002-2:2017

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

Published By Publication Date Number of Pages
ISO 2017-06 92
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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.

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ISO/TR 80002-2:2017
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