| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 01.04.2014 12:46:02 |
| Modified: | 27.02.2018 10:38:25 |
| Advanced : | |
| Appears In: | Perform clinical study based on CIP, 8.5.1 General, RM_Risk Management, Medical Device Reporting to NCAs |
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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
- «BusinessProcess» Medical Device Reporting (MDR) to NCAs
- Medical Device Reporting to NCAs
«Activity» Analysis of reported Adverse Event- «Activity» Do SAE reporting to BfArM according to MPSV (for CE approved devices only!)
- «Activity» Do SAE reporting to FDA (for FDA approved products only!)
- «Activity» Report to other country specific authorities
«StartEvent» Reported AE
«EndEvent» Reporting of AE assessed
«Gateway» AE regarded as SAE?
- «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