qmsWrapper eQMS - Traceability Matrix Mapping and Tracing Software
qmsWrappers Traceability Matrix has an innovative and unique approach to manage complex medical device products. Traceability is required by regulations and this tool helps you stay compliant.
You will have a quick and clear overview of your medical device life-cycle. With no hesitation, now you can freely change, edit any data because everything you input and output can be easily linked and traced.
You will instantly get transparent file tracking. Trace requirements through the numerous stages of development, where you will be able to see if any requirement is still uncompleted, and on the very end show they had been successfully addressed.
Our Traceability Matrix is integrated with Jira, QMS, Project Management, Document Management, making it the core of your DHF and Technical file. It’s the backbone of your 510k or CE Mark submission.
Traceability Matrix is driven with your QMS. The development of your medical device is driven by requirements of ISO 13485 and 21CFR 820. This way you will stay compliant and flexible responding to changes.
Since nobody is solely working on the project, we build the Traceability Matrix multi-user. Now you can work together with your team at the same time on the same matrix.
Achieve your goals, gain absolute control over your project. Quality is now ensured throughout the entire medical device life-cycle!
Awaiting audit? Great, you are ready! Our Traceability Matrix clearly demonstrates to inspectors/auditors the connection between the requirements, its design inputs, validation and verification, risk analysis, etc. No more wasting time seeking the required information, because it’s available to you with a single click.
qmsWrapper lets you build a Traceability Matrix for all your medical device regulatory needs.