| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 20.06.2014 14:13:03 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 7.4.1 Analyse changes to MEDICAL DEVICE SOFTWARE with respect to SAFETY, Manage SW Problem resolution |
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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
- Develop Software
- «BusinessProcess» Analyse, plan and concept
- «BusinessProcess» Design, implementation and integration
- «BusinessProcess» Do SW verification
- «BusinessProcess» Manage SOUP
- «BusinessProcess» Manage SW problem resolution [B,C]
- Manage SW Problem resolution
«Activity» Evaluate SW anomaly regarding impact and severity- «Activity» Integrate SW changes
- «Activity» Log detected SW anomaly
- «Activity» Make decision how to handle the SW anomaly
- «Activity» Perform statistic and trend analysis of SW anomalies
- «Activity» Update / repeat tests
- «Activity» Update SW design and SW verification plan
«StartEvent» Anomalie or problem detected
«EndEvent» Problem solved
«Gateway» Perform SW Change?
- «BusinessProcess» Manage SW stabilization
- «BusinessProcess» Release software
- «BusinessProcess» Review SW Phase 1
- «BusinessProcess» Review SW Phase 2.1
- «BusinessProcess» Review SW Phase 2.2
- «BusinessProcess» Review SW Phase 3
- «BusinessProcess» Review SW Phase 4
- «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
- «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
- Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox