The Medical Devices Regulation is there!
Loads of Paper © Andrii Kozachenko / Fotolia.com
We are facing a 560+ pages document and there needs to be a better way to work with it then scrolling around in the PDF or even on printed paper.
This is why we created a simple tool:
Here some screenshots. The red warning signs indicate that there is no traceable documentation for the item. This turns into green once a document has been attached to it.
The main screen shows the tree of all text objects in the MDR. You can expand and collapse the tree as you like.
you can add your notes to each text object with a simple editor.
Create relations to other documents: proceduredefinitions, V&V documents, cross-refereneces to other regulations, etc. AND you can also add different tags that establish a clean and bidirectional traceability. No questions anymore about why something is there! Searching for the answers is over then.
Established Traceability. Marked by a green sign on the left and by an attached document in the documents list.