Requirement Traceability Matrix Template 8 Examples (ISO 13485, Medical Device)

1. Record user needs and design inputs through the planning phase and update thereafter as appropriate.

In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before review of the document. All texts that are not blue are example texts that can and should be edited by you. Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text customized to work with the current project.

There are no requirements coming from risk management, usability or standards in this example. It may be appropriate to include such requirements depending on how you have set up your documentation structure. The user needs and design inputs in this template are from different types of products and should just be seen as examples.

In the design verification and design validation columns, references have been made to verification and validation protocoles. Some rows do not include this information as verification using review and analysis, might not require a verification protocol. The reference to the relevant protocol might not be available at once when writing the design input requirements and associated verification. The inclusion of verification and validation protocol references in this template implies that the project has come quite far.