ISO TR 80002-2:2017
(Main)Medical device software - Part 2: Validation of software for medical device quality systems
Medical device software - Part 2: Validation of software for medical device quality systems
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.
General Information
Standards Content (Sample)
TECHNICAL ISO/TR
REPORT 80002-2
First edition
2017-06
Medical device software —
Part 2:
Validation of software for medical
device quality systems
Logiciels de dispositifs médicaux —
Partie 2: Validation des logiciels pour les systèmes de qualité des
dispositifs médicaux
Reference number
ISO/TR 80002-2:2017(E)
©
ISO 2017
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ISO/TR 80002-2:2017(E)
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ii © ISO 2017 – All rights reserved
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ISO/TR 80002-2:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Software validation discussion . 1
4.1 Definition . 1
4.2 Confidence-building activities: Tools in the toolbox . 1
4.3 Critical thinking . 2
5 Software validation and critical thinking . 2
5.1 Overview . 2
5.2 Determine if the software is in scope . 6
5.2.1 Document a high-level definition of the process and use of the software . 6
5.2.2 Regulatory use assessment . 6
5.2.3 Processes and software extraneous to medical device regulatory requirements . 6
5.3 Development phase. 7
5.3.1 Validation planning . 7
5.3.2 Define . 7
5.3.3 Implement, test and deploy .11
5.4 Maintain phase .13
5.4.1 Entering the maintenance phase .
...
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