1 Scope
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
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— software used in the quality management system,
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— software used in production and service provision, and
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— software used for the monitoring and measurement of requirements.
It does not apply to
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— software used as a component, part or accessory of a medical device, or
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— software that is itself a medical device.