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

This webinar explains best practices for generating a design history file (DHF) for compliance with 21 CFR 820.30j and ISO 13485:2016, Clause 7.3.10.
21 CFR 820.30(j) - Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
This presentation includes specific documentation updates to comply with ISO 13485:2016 that was released on March 1, 2016 and how to integrate your design process with preparation of regulatory submissions such as a 510k or CE Marking submission.
Design History File (DHF) for 21 CFR 820.30j compliance
The most frequent category of FDA Form 483 inspection observation is design controls (i.e., 21 CFR 820.30). There are 10 different sections of the design controls requirement. Manufacturers that do not have design controls in place will frequently receive multiple observation findings during the same inspection-all related to design controls. The most common design control observations are:
1. A procedure for design and development has not been established in accordance with 21 CFR 820.30a
2. A procedure for design transfer has not been established in accordance with 21 CFR 820.30h
3. A procedure for design changes has not been established in accordance with 21 CFR 820.30i
4. A design history file (DHF) has not been established in accordance with 21 CFR 820.30j
If a manufacturer has no procedure for design controls, then the manufacturer could receive 4 different observations on FDA Form 483.
ISO 13485:2016 Requirements for Design Files
On March 1, 2016 the 2016 version of ISO 13485 was released. The new version of the Standard now requires procedures for design transfer, design changes and design and development files in an effort to be harmonized further with US regulatory requirements. Therefore, this presentation was created to specifically identify changes needed to your design controls procedure in order to comply with the latest version of the Standard.

[@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.