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?
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.
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?
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.
Thank you! Very helpful!
Glad it was helpful!