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New! From qmsWrapperTM

Traceability Matrix

Map and Trace the design control relationships for your medical device.

It's The Foundation of Your FDA DHF and CE Technical File

Capture requirements and their
traceability in a dynamic
multi-level cross-referencing tool.

  • Forward & Backward traceability completeness
  • Map requirements to test cases.
  • Map test cases to requirements.
  • Verify each test case is completed.

Organize, connect, trace and manage your design controls throughout the life-cycle.

  • Connect documentation to processes
  • Documentation is connected to approvals and version control
  • All requirement documentation in one place

TM is not only a starting point of our med-dev projects,
it is also the cornerstone of our Life-cycle process.

Sladjana B.
Project Manager

Manage & Track your projects design controls



Organize every input into the Traceability Matrix and show the details, revisions, history,
for every requirement,
ready for your submission.



Connect requirements to design specifications, to risk analysis, to SOPs, to test cases, to verification testing, to Validation, to OPS requirements, to whatever custom need your device development requires, etc…



Trace the relationships between requirements through the different stages of development and prove they have been successfully addressed.

Trace each requirement back to its original functionality and their testing. Trace each requirement to the device version history.

Track design changes and understand their impact on other changes and their relationships to the project.



Manage the project design control process through the life-cycle. Manage the CE Technical Files inputs and your FDA Design History inputs, managing the relationship between QMS, project management, and your team.



With TM you can track and trace all the relationships between the requirements in your project and to be sure and confident that your submission is ready.

Drazenka Z.
Quality Manager

Make your Job Easier

  • Integrated and synchronized with the project
  • Demonstrate that design was developed in accordance with an approved design plan and the requirements of 21CFR 820
  • Create custom verification and
    validation testing documents
  • Export into a print-ready format for your FDA submission
  • Flexibility to respond to changes
  • Reduce project risk

An essential tool to help you
prepare your FDA 510k, DeNovo or
CE Mark submission

You’ll never start another device project without it again.

I won't ever do another 510k submission without making
Traceability Matrix my starting point.

Ivana K.
Life Cycle and Product Development Expert

How it works

You build your Traceability Matrix as you develop your product...

Key Functions of qmsWrapper Traceability Matrix:

  • Track and show the relationships and connections between requirements
  • End to end traceability.
  • Design controls, by column.
  • Tracking numbers automatically assigned and inherited
  • Export into a print-ready format for your FDA submission - it is your DHF.
  • Integrated with document control
  • Integrated with processes
  • Integrated with Risk controls and Risk assessment
  • Integrated to approvals and version controls
  • Integrated and synchronized with the project
  • The cornerstone to your Life-Cycle processes.

Organize & Plan your FDA & CE submissions, from start to finish