ISO/TR 80002-2:2017

Current Revision
Medical device software - Part 2: Validation of software for medical device quality systems

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

PUBLISH DATE 2017

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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