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.
