How to you create a Design History File (DHF)?

[@mishelmk]

Thank you! Very helpful!

[@MedicalDeviceAcademy]

Glad it was helpful!

[@Ussie24]

Thanks a lot for these very insightful videos. Could you please make a video about Design Changes post-registration and how to document them? Does every design change demand an update of the DHF? All sections / documents or only what is actively driving the change?

[@MedicalDeviceAcademy]

We already created a training video on design changes, and it is specific to change made post-registration. it is a paid webinar: medicaldeviceacademy.com/design-changes-webinar/. We also have a procedure for these types of design changes (SYS-006). The webpage where we sell that procedure has two shorter videos about design changes on the page: medicaldeviceacademy.com/change-control-procedure/. We also created a blog about design changes and the letter to file process: medicaldeviceacademy.com/color-change/. To answer the second question you asked, no you should not update your DHF post-registration. Instead, you should be updating your DMR. If the change you are making is significant enough, then you will need a new 510(k) submission. In those situations, you create a new DHF for the design change--not update the old DHF. Your third question is suggesting that the DHF is like a technical file or design dossier with sections and documents that are updated in a "living" design history file. That is not the intent of the DHF. The DMR is the "living" file that has the current version of each document and file.