ISO/TR 80002-2:2017(E) 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.
| CSA Group | |
|---|---|
| Product Category | Standards and Technical Documents |
| Product Number | ISO TR 80002-2:2017 |
| Product Name | Medical device software - Part 2: Validation of software for medical device quality systems |
