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Medical device software -- Validation of software for medical device quality systems
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.
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