Design History File - Medical Device Quality Systems Manual Section 3, Design Control

M

Mark Smith

#1
Design History File


Any ideas on the format I should use when my device is designed to be used WITH a drug? I am leaning towards a separate DHF for the device(s) and whatever the equivalent to a DHF is for the Drug. Suggestions? By the way I'm new to the site and not the same Mark as the site Administrator.
 
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D

Don Winton

#2
I am leaning towards a separate DHF for the device(s) and whatever the equivalent to a DHF is for the Drug.
That would be my suggestion. From the Medical Device Quality Systems Manual, Section 3, Design Controls:

"Typical documents that may be in, or referenced…"

Key word is referenced. Make a reference to the equivalent of a DHF for drugs in the device DHF.

Another reason to maintain two DHF's is simplicity. Make the documents as simple to audit as possible and then the probability of an error of exclusion is less.

Regards,
Don

------------------
Just the ramblings of an Old Wizard Warrior.
 
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