1. Medical Device - Design and Development Planning:

• Medical Device – Overview of Master Project Plan (MPP)
• Medical Device – Integrated Design Plan (IDP) Checklist
• Medical Device –  RiskManagement Plan and Risk Analysis
• Medical Device –  Reliability Plan
• Medical Device –  Packaging and Handling and Environmental Test Plan

2. Medical Device - Design Input:

• Medical Device – User Requirement Document (URD)
• Medical Device – Product Requirement Document (PRD)
• Medical Device – Software Requirement Specification (SRS) or
• Medical Device – Firmware Requirement Document (FRD)
• Medical Device – Design Input Label Requirement (DILR)

3. Medical Device - Design Output:

• Medical Device – Hardware Detailed Design Document  (HDD)
• Medical Device – Software Detailed Design Document  (SDD) or
• Medical Device – Firmware Detailed Design Document  (FDD)

4. Medical Device –Verification and Validation:

Test Execution Hardware

• Medical Device – System Functionality Verification Test Protocol or Report
• Medical Device – Physical Characteristics Verification TestProtocol or Report
• Medical Device – Regulatory, Safety and Standard Verification Test Protocol
• Medical Device –User Interface and System Characteristics  Verification Test
• Medical Device –DILR Verification TestProtocol or Report
• Medical Device – Impedance Verification Test Protocol or Report
• Medical Device –Biopotential Verification TestProtocol or Report
• Medical Device – Myogenic Noise Verification TestProtocol or Report
• Medical Device –Packaging and Handling and Environmental Verification Test
• Medical Device –Cleaning Verification TestProtocol or ReportTest Execution Software/Firmware
• Medical Device –Device Core Features Verification Test
• Medical Device –ABR Screening Verification Test
• Medical Device –PCA/ATA Cable Connections and Calibration Verification Test
• Medical Device –Device Setup Verification Test
• Medical Device –Master Verification report
• Medical Device –Traceability Matrix

5. Medical Device – Design Transfer