There are some important factors to keep in mind in order to have a complete DHF. First we have to keep up with it as you go. Throughout the process, you have to keep an eye on every change you make and update the DHF accordingly. Second factor is to store it separately from your project file, because otherwise it will get messy with all the other notes and things that go into product development. It has to be clean and ready to present whenever you are asked for it. The last factor is to make sure the whole team has access to it. Everyone who contributes to the project should be able to make notes and update the DHF.
Within the DHF lives everything about how you’re meeting Design Controls. Without Design Controls, you won’t be complying with regulations. And lack of compliance means increased exposure during FDA inspections. So make sure you include all design control documents, meeting minutes, all research protocols, clinical and pre-clinical, all notes, and all market research.