Documents

Number Title Revision Status edit
FORM-0001 Development Plan 00 Draft
FORM-0002 Development Checklist 00 Draft
FORM-0003 Document Change Order 00 Draft
FORM-0004 Document Approval Form 00 Draft
FORM-0005 Requirements Document Form 00 Draft
FORM-0006 Product Specification Form 00 Draft
FORM-0007 Traceability Form 00 Draft
FORM-0008 TCR Form and Test Sheets 00 Draft
FORM-0009 Verification and Validation Protocol 00 Draft
FORM-0010 Verification and Validation Report 00 Draft
FORM-0011 Risk Management Plan Form 00 Draft
FORM-0012 Concept Diagram Form 00 Draft
FORM-0013 Critical Parameter Form 00 Draft
FORM-0014 User Feedback Form 00 Draft
FORM-0015 Bill of Material Form 00 Draft
FORM-0016 DFMEA Form 00 Draft
FORM-0017 Root Cause Analysis (SFTA) Form 00 Draft
FORM-0018 Five Whys Analysis Form 00 Draft
FORM-0019 VnV Plan Form 00 Draft
FORM-0020 VnV Summary Report Form 00 Draft
FORM-0021 Rework Form 00 Draft
FORM-0022 Service Case 00 Draft
FORM-0023 Complaint 00 Draft
FORM-0024 Corrective and Preventive Action (CAPA) Form 00 Draft
FORM-0025 Training Documentation Form 00 Draft
FORM-0026 Software Development Plan 00 Draft
FORM-0027 IEC 62304 Traceability Matrix 00 Draft
FORM-0028 Technical Investigation 00 Draft
FORM-0029 Software Bug Form 00 Draft
FORM-0030 Software Development Checklist 00 Draft

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