Traceability Baselining in the Design Process

Traceability Baselining in the Design Process

Capturing the Design History File and the Device Master Record are two examples of document structures that are required by the regulatory bodies. They are associated to a device or a product, and we need to be able to capture changes to them. This can in many cases be a manual tedious task to complete.

Having a system that allows you to create as many regulatory structures you want to manage and have them managed in the same way so that they are automatically created, tracked and baselined should be a standard requirement in the medical device industry.

Other document structures such as the Technical File could also benefit from being managed in the same way as the DHF and the DMR.

In this video, we will show you how you can handle these document structures in the same way with the same requirements for change management and traceability and achieve:

  • Accurate project update status
  • Faster documentation retrieval
  • Improved visibility
  • Decreased risk of errors
  • Efficient regulatory submission workflow that is futureproof