Design Input Requirements Control Matrix

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A Design Input Requirements Control Matrix is a Controlled Document that identifies in a tabular format each device input requirements. The matrix may be devided into individual sections for major elements of the input requirements. For example:

  • Intended use
  • User needs
  • Patient needs
  • Operational requirements
  • Standard requirements
  • Safety requirements
  • Performance requirements
  • Environmental requirements
  • Labelling requirements
  • Packaging requirements
  • Documentation requirements

The document will be subject to version control.