| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 03.05.2014 11:55:46 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices, CFR 820.184 Device history record, Build device, 7.5.9.2 Besondere Anforderungen für implantierbare Medizinprodukte |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
Process landscape
Management- Quality and Regulatory
- Clinical Marketing
- Research and Development
- Operations
Operations- IE_Industrial Engineering
- LG_Logistics
- PD_Production
- PD_Production
«Activity» Build device- Build device
- «Activity» Create DHR
- «Activity» Document device complete
- «Activity» Document device manufacturing
- «Activity» File modules build into device
- «Activity» Label device and affix CE mark
- «Activity» Manufacture device
- «Activity» Prepare device manufacturing
- «Activity» Receive production order and type plate for device
- «Activity» Store device
- «Activity» Take production modules from stock
- «Activity» Take production parts from stock
«EndEvent» Device built
«StartEvent» Need for new devices
«Gateway» Device blocked?
- «Activity» Build module
- «Activity» Build sterile modules
- «Activity» Do module acceptance test
- «Activity» Inspect new parts
- «Activity» Manage nonconformities of parts
- «Activity» Manage nonconformities of production process
- «Activity» Manage production
- SCM_Supply chain management
«BusinessProcess» Plan resources and budget Operations- «BusinessProcess» Report Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox