Matrix Requirements Medical

Have your team maintain your device history file (DHF) while it is being designed, not before, not after MatrixALM will help you to ensure the content is correct and support you in creating the documents for certification

Agile Quality Management System

Have processes and work instructions which are simple, efficient and easy to use and improve, not SOPs written by someone else for someone else MatrixQMS will help create a quality system which works for you, not against you

Risk management needs to be integrated in the design process and the quality system, not in some Excel file on some server With our applications, the risks are part of the traceability matrix

Plan and document your verification and validation activities while you design your device, not once you think you are ready to release MatrixALM provides the full traceability matrix from the requirements until the executed tests

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Using Matrix Requirements for Medical Device Development