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// The first line should include the project name // The second and on at the same level will be the upper level // To add a sub level, use the TAb key CAFU Project Management Planning Scope management Change management Task management Schedule management Project communications Human resources management Risk management Quality management Development Master Plan Concept Product Description General Device Description Indications for Use Principles of Operation Components Accessories Compatibility XXX to be completed Requirements Specifications Medical Device Classification Essential Requirements Draft Functional Specifications Systems Engineering Technical planning Technical supervision Business requirements definition System requirements definition System architecture top level design Prototype Camera Console Housing Front Module Electronics Lamp Module Single Board Computer Integration Camera Head Cable Combo Camera Head Cable Ocular Accessories Sterilization Tray Power Cable DVI Cable Video Cable Sterilization Sheath Packaging Software Software Design Software requirements specifications Software work package definition Software prototyping Software unit detail design Software Build Software unit coding Software unit debugging Unit Testing Unit test planning Unit test case preparation Unit test conduct Unit test records Hardware Hardware requirements planning Hardware system definition Hardware component selection Hardware unit/component testing Deliverable Management Deliverable tracking Deliverable production packaging Design Documentation Design Specification HW Control Unit Drawings Control Unit BOM Control Unit Materials Control Unit Datasheet Control Unit Design Specification HW Camera Head Drawings Camera Head BOM Camera Head Materials Camera Head Datasheet Camera Head Design Specification Electronics Block Diagram Isolation Diagram List of Critical Components Datasheets / Certificates Critical Components Schematics Layouts Datasheet Electrical Components RoHs Statement Design Specification SW Control Unit Software Specification Software Architecture Software Development Process Software Risk Classification Software Documentation Design Specification SW SBC SW Description SW Source Code Design Specification Packaging Packing List Drawings Package Materials Package Labeling Device Label Control Unit Device Label Camera Heads Device Labels Accessories Packaging Label System Packaging Label Control Unit Packaging Label Camera Heads Packaging Labels Accessories Risk Management Risk Management File Risk Management Plan Risk Analysis Risk Control Measures Risk Report Usability Engineering File Concept of Use Concept of Design Article Definitions Verification Documentation Internal Prototype Testing Standards Testing Usability Testing Internal Workshop XXX to be completed Verification Planning Test planning Module subsystem testing System integration testing Acceptance testing Defect classification, tracking metrics Manufacturing Documentation (Design Transfer) Work Instruction HW Test Instructions HW Test Report Template HW XXX mit allen systemkomponenten ergänzen Incoming Goods Control Work Instruction Test Report Outgoing Goods Control Work Instruction (STK, Function, ect) Test Report Packaging Instructions DHR Template Service Manual Work Instruction Installation Tower Support Services Configuration management Quality assurance Development tools utilities Development environment Internal product liaison Team technical training Installation Installation planning User support documentation User communications training Installation management coordination Installation testing verification Installation performance monitoring
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