| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 14.03.2014 11:44:41 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 6.2 Risk control option analysis |
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Overview- Organisation Chart
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- SOPs
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- Software tools
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- Compliance
Compliance
ISO 13485:2016-08 Qualitätsmanagement- ISO 13485:2012-11 Quality management
- ISO 14971 Risk management
- ISO 14971 Requirements
- 2 Terms an definitions
- 3. General requirements for risk management
- 4. Risk analysis
- 5. Risk evaluation
- 6. Risk control
- 6. Risk control
- 6.1 Risk reduction
- 6.2 Risk control option analysis
6.2 Risk control option analysis
«Functional» 6.2 Identify risk control measures that are appropriate for reducing the risk to a acceptable level- «Functional» 6.2 a) Risk control by inherent safety by design
- «Functional» 6.2 b) Risk control by protective measures in the medical device or the manufacturing process
- «Functional» 6.2 c) Risk control by information for safety
- «Functional» 6.2 Record risk control measure in the risk management file
- «Functional» 6.2 If the required risk reduction is not practicable, conduct a risk / benefit analysis
- 6.3 Implementation of risk control measures
- 6.4 Residual risk evaluation
- 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
- 8. Risk management report
- 9. Production and post-production information
- Anhang ZA
- IEC 62304 Software life-cycle processes
- IEC 62366 Usability
- CFR 820 Code of Federal Regulations Title 21
- Council directive 93/42/EEC, Annex II
- ISO 27001 Information technology - Security techniques
- IEC 60601-1 Processes
- Sandbox