| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 03.11.2008 11:45:57 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 5.2.3 Include risk control measures in software requirements, 4.1.3 Information for SAFETY, Templates, Manage CAPA process, Analyse, plan and concept , 5.3.2 Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS, 5.5 USABILITY SPECIFICATION, 5.6 USABILITY VALIDATION plan, Appraisal of individual data sets, Create application training material, Do AE surveillance, Prepare and apply for clinical study, 7.3.3 Entwicklungseingaben, Do device hazard analysis, Determine risk matrix, 3.2 Absatz 3 (c), Do Design-FMEA, Create USI, 4.2.2 General requirement for RISK MANAGEMENT, European Technical File (ETF), 4.2 Intended use and identification of characteristics related to the safety of the medical device, 4.7 Single fault condition |
Properties :
Files :
| File | Size | Last Updated | Notes |
| http://cloud.optana.de/index.php/apps/files/ajax/download.php?dir=%2FCompliance%20Master%2FTemplates&files=Device%20hazard%20analysis%20(DHA).docx | 584 k | 13.11.2014 08:34:42 |