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hello and welcome to my next executive series video our topic device history file aaron snyder here from quality systems explained where we make quality systems simple for you if youre new to my channel please hit the subscribe button if this is the first executive series video that youve seen please go back and look at the executive series introduction in the video description below you can find links to all supporting information and a summary of the information that we will cover in my executive series we have four main agenda items you can see those in the progress bar below make sure you stick around to the end for those three bonus questions our requirement today device history file comes directly from 820.30j and iso 1345 section 7.3.10 device history file in five words maintain records proving regulatory compliance you have to have a procedure that defines how you manage your device history file when you think of the device history file what i want you to think about is its
