PD ISO/TR 80002-2:2017
Current
The latest, up-to-date edition.
Medical device software Validation of software for medical device quality systems
Hardcopy , PDF
English
10-31-2017
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
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