| General : | |
| Version: | 1.0 |
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| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 14.03.2014 14:43:06 |
| Modified: | 27.02.2018 10:37:57 |
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| Advanced : | |
| Appears In: | RD_Research and Development, 5.2.4 Re-evaluate medical device risk analysis, 6.5 Risk-benefit analysis, 6.6 Risks arising from risk control measures, 6.7 Completeness of risk control, 7. Evaluation of overall residual risk acceptability, 5.9 USABILITY VALIDATION, 4.2 Risk management, RM_Risk Management, 7.3.3 Entwicklungseingaben, 7.1 Planning of product realization, 7.3.2 Design and development inputs, Create SysRS / US, 3.2 Absatz 3 (c), Do Design-FMEA, 3.1 Risk management process, 3.4 Risk management plan, Anhang ZA, Create PRS, CFR 820.30 Design controls, 6.1 * Establish software maintenance plan, 4.2.2 General requirement for RISK MANAGEMENT, 5.7.3 Retest after changes, 5.1.7 Software risk management planning, 7.3.3 Document TRACEABILITY, 3.5 Risk management file, 4.1 Risk analysis process, 4.3 Identification of hazards, 4.4 Estimation of the risk(s) for each hazadous situation, 6.2 Risk control option analysis, 6.3 Implementation of risk control measures, 6.4 Residual risk evaluation, 4.7 Single fault condition |