The most valuable, strategic early-phase action you can do is to define the traceability structure of your Design Controls.

This structure is used to drive your development forward, detect gaps and ultimately provide you with a complete, consistent, and correct Technical File.

Let Aligned Elements create traceability matrices tailored to standards like IEC 62304, IEC 62366 and ISO 14971, as well as your own quality system and development SOP's.

Keep your traceability complete and consistent while staying focused on the design itself. 

Settings traces should be easy. Wherever you are in the project, trace actions are right there with no switching views, no extra steps.

Whether you are dragging and dropping between items, selecting from smart search lists, or creating and tracing in one step, it is all designed to be fast and frictionless.

You can resolve errors and set traces in the same move, apply batch changes across large sets, and manage traces seamlessly across multiple projects.

Making traceability this easy means fewer disruptions, fewer missed links, and a lot more confidence in your data.

Large medical device project can involve thousands of traces. The sheer scale increases the risk of unintentionally missing relevant trace connections.

With AI-powered assistance, you can explore, compare, and contrast trace candidates from our AI with your own selection. 

Eliminate traceability errors with our built-in impact analysis of trace changes, provided to understand the impact of the change in the current project context.

Run continuous real-time consistency checks to detect traceability gaps and perform Trace Analysis at any time to detect missing, illegal, suspect, and obsolete traces.

Solve trace problems by selecting among Aligned Elements' suggested solutions with a single click. Detecting traceability problems and taking action to solve them has never been easier. 

Build your own customized trace tables and matrixes on-the-fly, in the built-in Trace Table Designer.

Generating a populated end-to-end trace table, based on your own Trace Table Design, is completed within seconds.

Inspect the results, make modifications to the table design if necessary, or go straight to publish the relevant documents.

Export the traceability matrix to Word or Excel or insert it directly in your Technical File Documents, using our unique Word Add-In.

A single click is all it takes to update your documents containing traceability matrices, populating them with the latest traceability information.