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| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 14.03.2014 14:07:35 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 4.2.3 Medizinproduktakte, Templates, Analyse, plan and concept , 4.2.4 Control of records, Manage and create PCRs, 7.3.3 Entwicklungseingaben, Create SysRS / US, Do device hazard analysis, Create PRS, Create USI, Determine basic product characteristics, 5.1.3 Software development plan reference to system design and development, 4.4 Expected Service Life, Design History File, 4.6 ME Equipment or ME System parts that contact the patient |