PD ISO/TR 80002-2:2017

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Software validation discussion
5 Software validation and critical thinking
6 Documentation
7 Prerequisite processes
Annex A (informative) - Toolbox
Annex B (informative) - Risk management and
        risk-based approach
Annex C (informative) - Examples
Bibliography

Pertains 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 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 ISO13485 .

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.