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Intended Use

MatrixALM is intended to be used to create and maintain documentation for medical devices. It includes functions to document design input and output, including risks, tests and test results and manages the traceability in between.

The user guide is split in two sections. General usage and specific functions and workflows

Part 1: General Usage

This part explains how to 

  • add and edit design input and output (such as requirements, specifications, risk, test cases etc.),

  • view the history of an item and compare revisions,

  • establish, analyze and fix the traceability.

Part 2: Advanced Usage

This part explains how to

  • create, organize edit and execute tests,

  • create reports,

  • configure and use the risk analysis tool,

  • manage product configurations,

  • setup and  use review workflows,

  • create and manage controlled documents,

  • archive and electronically sign documents.

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