(diy) DHF Templates

Compliant. Easy to use. Exhaustive.
Streamline your FDA or EU submission with our SaMD/SiMD regulatory kit. This (diy) kit includes a full set of design history file (DHF) templates and training that provides regulatory guidance aligned with best practices.

  • Software Development Plan
  • Software Requirements Analysis
  • Software Architecture
  • Software Risk Management Plan
  • Software Hazard Analysis
  • Software Requirements Traceability Matrix
  • Software Configuration Management Plan
  • Software Detailed Design
  • Software DFMEA
  • Software Design Review
  • Software Verification & Validation Plan
  • Software Verification Protocol
  • Software Verification & Validation Summary Report
  • Software Release Notes
  • Software Risk Management Report
  • Software Configuration Management Worksheet (SBOM)
Tool Validation​
  • Tool Validation Plan
  • Tool Validation Assessment
  • Tool Validation Protocol
  • Tool Validation Report
  • User Needs
  • Usability Plan   
  • Usability Protocol   
  • Usability Test Report 

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