Traceability Matrix Template: Translate User Needs into Actionable Design Inputs

Designing a medical device that meets user needs is paramount to:

• Meeting the FDA’s rigorous standards and design controls,

• Pleasing your end users, and

• Creating the right product for the current market.

Despite its importance, actually taking your user needs and seamlessly incorporating them into your design doesn’t come easily. One way to simplify the process for yourself? Use a traceability matrix.

A traceability matrix helps you define and track product requirements to reduce risk and carry initial insights through to realized products. Our template and traceability matrix explainer guide will get you started.