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OverviewOrganisation ChartStaffRolesProjectsSOPs
Process landscape
ManagementQuality and RegulatoryClinical MarketingResearch and Development
Research and DevelopmentIP_IP-ManagementRD_Research and DevelopmentRD_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«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 phaseID_Industrial DesignOperationsCustomer SupportSalesFinanceInformation TechnologyHuman ResourcesTemplatesSoftware toolsEquipmentFacilitiesProductsComplianceSandbox| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 27.06.2014 10:30:38 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | Do SW Validation , 7.3.7 Entwicklungsvalidierung |
Properties :
Files :
| File | Size | Last Updated | Notes |
| http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm |
