| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 14.03.2014 15:09:00 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 5.5 USABILITY SPECIFICATION, Do device hazard analysis, 4.2.2 General requirement for RISK MANAGEMENT, 4.7 Single fault condition |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
Process landscape
Management- Quality and Regulatory
Quality and Regulatory- QA_Quality Assurance
- QM_Quality Management
- RA_Regulatory Affairs
- RM_Risk Management
- RM_Risk Management
«BusinessProcess» Determine risk matrix- «BusinessProcess» Do device hazard analysis
- Do device hazard analysis
«Activity» Assure that all known hazards were assessed- «Activity» Determine if all defined measures were implented and verified
- «Activity» Determine if medical benefit is grater than residual risk
- «Activity» Determine residual risk to be published
- «Activity» Analyze potential hazards and probability
- «Activity» Determine related effects and severity
- «Activity» Determine risk before mitigation
- «Activity» Determine risk mitigations
- «Activity» Evaluate new risks induced by DHA mitigation
- «Activity» Determine risk after mitigation
- «Activity» Determine risk acceptability
- «Activity» Justify medical benefit / risk ratio for specific hazard
«StartEvent» New potential hazard
«EndEvent» Potential hazard assessed
«Gateway» New risks?- «Gateway» Risk acceptable?
- «BusinessProcess» Medical Device Reporting (MDR) to NCAs
- «BusinessProcess» Plan resources and budget Q&R
- «BusinessProcess» Report Q&R
- Clinical Marketing
- Research and Development
- Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox