(diy) Regulatory Kit

Required. Affordable. Easy to use.

Save $200k and 10 months in preparation with our SaMD/SiMD regulatory kit. This do-it-yourself kit includes a full set of design
templates required by the FDA for your submission or technical file.

Our kit also includes associated processes and training that provides you with guidance and best practices to help you complete your design history file (DHF).

Planning​
  • Software Development Plan
  • Software Requirements Analysis
  • Software Architecture
  • Software Risk Management Plan
  • Software Hazard Analysis
  • Software Requirements Traceability Matrix
Development​
  • Software Configuration Management Plan
  • Software Detailed Design
  • Software DFMEA
  • Software Design Review
Verification​
  • 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
Usability​
  • User Needs
  • Usability Plan   
  • Usability Protocol   
  • Usability Test Report 

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