Medical device software - Validation of software for medical device quality systems
Medical device software - Validation of software for medical device quality systems
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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
— 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.
Упомянутые в описании и другие стандарты PD