TM is now more effective and useful feature that serves as a dashboard for product development leading to submission.

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

qmsWrapper: screenshot of Traceability Matrix

Key functions of qmsWrapper Traceability Matrix:

  • track and show the relationships and connections between requirements
  • end to end traceability
  • design controls, by column
  • tracking number automatically assigned and inherited
  • export into a print-ready format for your FDA submission- it is your DHF
  • integrated with document control and risk control 
  • integrated with processes, approvals and version controls
  • integrated and synchronized with the project
  • it's the cornerstone to your Life-Cycle processes


Traceability Matrix for your Design History File or Technical File


It helps track project requirements through steps that connect the dots.
Clearly demonstrates to inspectors/auditors the connection between the requirements, its design inputs, validation and verification, risk analysis, etc.



Notable features of Traceability Matrix?

  • Multi-User implementation. All members of the team can work at the same time on the same TM
  • Risk Assessment can be created from within the Traceability Matrix to go feature by feature
  • Jira Integration - link Jira tasks, to testing, testing to validation

Traceability Matrix by qmsWrapper integrates with Jira, QMS, Project Management and Document Management. Requirements, specifications, design inputs and outputs, testing, life-cycle makes the core of DHF and TM and the backbone of 510k
or CE Mark submission.


qmsWrapper Traceability Matrix

Comments (3)

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I have heard very good reviews of your software, lately. My company will apply for Live Demo probably.

We are very happy to hear that because it confirms that we are doing good work. Waiting for your request :)

Dear Team, if we apply for live demo, can we see how your Traceability Matrix is working? Is it possible to show us? We are interested in your software.
Thank you,