| General : | |
| Version: | 1.0 |
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| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 27.02.2014 19:15:14 |
| Modified: | 03.09.2019 15:55:16 |
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| Advanced : | |
| Appears In: | 7.1.4 Document potential causes, 7.1.5 Document sequences of events, 7.2.1 Define RISK CONTROL measures, 7.2.2 RISK CONTROL measures implemented in software, 7.4.1 Analyse changes to MEDICAL DEVICE SOFTWARE with respect to SAFETY, 7.4.2 Analyse impact of software changes on existing RISK CONTROL measures, Develop System, Create DRS, 7.3.3 Document TRACEABILITY, 7.1.2 Identify potential causes of contribution to a hazardous situation, 7.1.3 EVALUATE published SOUP ANOMALY lists |