| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 26.05.2014 14:37:09 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 7.5.3.2.1 General, 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices, 7.5.9.2 Besondere Anforderungen für implantierbare Medizinprodukte, CFR 820.65 Traceability, Create DMRs and MMRs |
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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
Research and Development- IP_IP-Management
- RD_Research and Development
- RD_Research and Development
«BusinessProcess» Determine basic product characteristics- «BusinessProcess» Develop Software
- «BusinessProcess» Develop System
- «BusinessProcess» Do SW validation
- «BusinessProcess» Do system / usability verification
- «BusinessProcess» Manage tools and equipment RD
- «BusinessProcess» Plan integration and build functional model
- «BusinessProcess» Plan resources and budget RD
- «BusinessProcess» Provide SERVICE LEVEL 3
- «BusinessProcess» Report RD
- «BusinessProcess» Select and qualify development partner
- «BusinessProcess» Select and qualify development tools
- «BusinessProcess» Start development project
- «BusinessProcess» Manage development process
- «BusinessProcess» Manage engineering change requests (ECRs)
- «BusinessProcess» Create SysRS / US
- «BusinessProcess» Create DRS
- «BusinessProcess» Create DMRs and MMRs
- Create DMRs and MMRs
«Activity» Create BOM for device- «Activity» Create BOM for module
- «Activity» Create DMR
- «Activity» Create MMR
- «Activity» Create TSC instructions
- «Activity» Create acceptance test instructions
- «Activity» Create assembling instructions
- «Activity» Create incoming device inspection instructions
- «Activity» Create installation instructions
- «Activity» Create installation test instructions
- «Activity» Create labeling instructions
- «Activity» Create packaging instructions
- «Activity» Create packing list for device including accompanying documentation
- «Activity» Create scrapping instructions
- «Activity» Create spare part list
- «Activity» Create storage instructions
- «Activity» Define device / module / work environment traceability
- «Activity» Module specifications
- «Activity» Release module for production
«EndEvent» Design transfer executed
«StartEvent» Ready for design transfer
- «BusinessProcess» Do Design-FMEA
- «BusinessProcess» Do product training
- «BusinessProcess» Do module verification
- «BusinessProcess» Review design phase
- «BusinessProcess» Review design transfer
- «BusinessProcess» Review product release
- «BusinessProcess» Review requirement phase
- «BusinessProcess» Review validation phase
- «BusinessProcess» Review verification phase
- ID_Industrial Design
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