missing-documents

Product Design Phase 1 Checklist. Software Design Phase 2 Checklist. Documentation level FDA PHA Checklist Security Risk Management Plan Security Risk Matrix AI/ML Description AI/ML Development Plan Data Collection Instructions Data Annotation Instructions SF14.20_Regulatory Requirement SF26.02_Security Risk Assessment Report SF15.01_Commissioning Checklist

SF14.03_Software Requirement Specification SF14.04 Software Tests Plan SF14.05_Software Architecture Description SF14.06_Software Test Report SF14.10_Version delivery description (Design transfer) SF14.11_Software configuration management plan SF14.12_Software Test Description SF14.13_Software Detailed Design (class c) SF14.14_Traceability Matrix SF14.15_Documentation level FDA SF14.16_Software Classification 62304 SF14.17_Product requirements SF14.18_Device Description SF14.19_Intended use SF14.20_Regulatory Requirement SF14.21 SOUP List