There is some reference to this subject in the modules for this course and the Medical Device Development course.

One school of thought says that the DHF is sealed at the end of Design Transfer and never altered again. Any alterations to the devices SOP’s, labeling, packaging, etc. can be added to the DMR so long as they are not changing the nature or indications of the device.

So for example, if the SOP for device assembly was originally written before Design Transfer and is hence contained in the DHF, the next revision to that SOP which is made after Design Transfer does not need to be copied to the DHF. It can be inserted into the DMR and that’s fine. This is because the purpose of the DHF is to document the original thought and planning that went into the device, not the ongoing changes.

Of course, if the design changes purpose, indications, drastic look and feel, and other things of major importance, it may be time to consider a whole new project and maybe even a new DHF. It is essentially a whole new device and gets all of its own documentation.

The other school of thought says that the DHF is updated regularly as things within it change, even after Design Transfer is complete. The DHF is a snapshot in time that shows the device as it exists right now, and always now.

What school of thought appeals to you most and why?