| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 14.03.2014 14:49:34 |
| Modified: | 27.02.2018 10:38:12 |
| Advanced : | |
| Appears In: | RM_Risk Management, Determine risk matrix, 3.2 Management responsibilities, 3.4 Risk management plan, Anhang ZA, 4.2.2 General requirement for RISK MANAGEMENT, 4.4 Estimation of the risk(s) for each hazadous situation, 5. Risk evaluation |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
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- 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- Determine risk matrix
«Activity» Create risk matrix- «Activity» Determine product specific hazards and effects
- «Activity» Determine risk acceptance criterion
- «Activity» Determine specific probability levels
- «Activity» Determine specific severity levels
«StartEvent» Creation of new MD
«EndEvent» Risk matrix defined
- «BusinessProcess» Do device hazard analysis
- «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