Intended Use

Matrix Requirements Medical is a web based application which supports companies with development and documentation of medical devices or parts thereof. It allows users to store design input and output in a secure database, analyze the data for completeness and correctness and create controlled documents with electronic signatures needed to certify the device.

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

Part 1: General Usage

• add and edit design input and output (such as requirements, specifications or test cases),
• view the history of an item and compare revisions,
• establish, analyze and fix the traceability,
• create, organize edit and execute tests,
• create reports.

Part 2: Advanced Usage

• 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.