An effective traceability process is essential requirements when developing medical device software and to achieving regulatory compliance.
Traceability Matrix can be very difficult to create, it can take months to put together manually, especially without a proper tool. Creating and maintaining a TM can be time-consuming and difficult not to mention all those messy spreadsheets and ongoing updating struggles!
With the right tool, a TM can significantly reduce your project risk and set the foundation of your product lifecycle – not to mention make your job easier and put you in control of your project.
qmsWrapper™ lets you build a Traceability Matrix for all your medical device regulatory needs. It will be the cornerstone of the DHF or CE Technical File.
The Traceability Matrix in qmsWrapper™ is fully integrated into the project and quality management. It supports linked documents in storage and allows you to use qmsWrapper’s customizable forms to create custom verification and validation testing documents that will link, track and show the connections between each.
You’ll never start another device project without it again. qmsWrapper Traceability Matrix will make your regulatory life a lot easier.
Prove your claim that you follow recognized industry practices for validation, with qmsWrapper Traceability Matrix.