ISO/TR 80002-2:2017

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

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.

Edition	2017
Standard Part No	2
Published Date	2017
Published By	International Standardization Organisation/Technical Reference
Page Count	84