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  • aaq2 replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls 7 years, 5 months ago

    If one desires to reproduce the device then the DHF will be the way to go. For a summary I believe the tech file would be more useful. The tech file might eliminate the cumbersome information that is not required at the time of approval which may lead to a quicker approval.

    Being that the DHF has more detailed information from day one to production, all changes to the design and device flaws will be captured in this file. This will prevent similar mistakes from occurring if there should be an improvement to the device in the near future. Should a device flaw be found I believe the DHF would be a better file to have than a tech file which means less expenditure to rectify the issue.