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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Software validation discussion
4.1 Definition
4.2 Confidence-building activities: Tools in the toolbox
4.3 Critical thinking
5 Software validation and critical thinking
5.1 Overview
5.2 Determine if the software is in scope
5.2.1 Document a high-level definition of the process and use of the software
5.2.2 Regulatory use assessment
5.2.3 Processes and software extraneous to medical device regulatory requirements
5.3 Development phase
5.3.1 Validation planning
5.3.2 Define
5.3.3 Implement, test and deploy
5.4 Maintain phase
5.4.1 Entering the maintenance phase
5.4.2 Planning for maintenance
5.4.3 Types of maintenance within the maintain phase
5.4.4 Process changes: Change to risk control measures
5.4.5 Emergency change
5.4.6 Maintaining for intended use
5.5 Retirement phase
6 Documentation
7 Prerequisite processes
Annex A (informative) Toolbox
Annex B (informative) Risk management and risk-based approach
Annex C (informative) Examples
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Software validation discussion
4.1 Definition
4.2 Confidence-building activities: Tools in the toolbox
4.3 Critical thinking
5 Software validation and critical thinking
5.1 Overview
5.2 Determine if the software is in scope
5.2.1 Document a high-level definition of the process and use of the software
5.2.2 Regulatory use assessment
5.2.3 Processes and software extraneous to medical device regulatory requirements
5.3 Development phase
5.3.1 Validation planning
5.3.2 Define
5.3.3 Implement, test and deploy
5.4 Maintain phase
5.4.1 Entering the maintenance phase
5.4.2 Planning for maintenance
5.4.3 Types of maintenance within the maintain phase
5.4.4 Process changes: Change to risk control measures
5.4.5 Emergency change
5.4.6 Maintaining for intended use
5.5 Retirement phase
6 Documentation
7 Prerequisite processes
Annex A (informative) Toolbox
Annex B (informative) Risk management and risk-based approach
Annex C (informative) Examples
Bibliography