TF vs DHF

MrTetris

Involved In Discussions
#1
Hello everyone,
I am traying to understand if this substantial difference between DHF and TF is a bad habit of my company, or it is actually reflected in regulation/standards :)
DHF: it is required to collect the history of the device development. It should be traceable when a certain update of the design has been made. Therefore, we keep documentation from all Design Change separate:
Device 1 DHF:
- Original
- DC1
- DC2
...

TF: it should store only the documentation related to the current device in production. Therefore, no structure is needed (we actually have "current" and "obsolete" folders, but I cannot track back what TF documentation was in place at the time of an old DC).

Is that allowed by regulations/standards? Thank you in advance for your attention!
 
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chris1price

Trusted Information Resource
#2
The DHF (Design History File) is defined under FDA 21CFR 820.30.

The phrase "Technical File" is not defined in a regulation or standard and can have many meanings. for example:
Device Master Record (DMR) defined under 21CFR820.181
Medical device file, ISO13485 pt 4.2.3
GHTF STED
MDR..... etc

From your definition,. it sounds like you are referring to the DMR. This should be linked to the batch, so you can identify the version of the DMR in use for any particular batch.
 

MrTetris

Involved In Discussions
#3
The DHF (Design History File) is defined under FDA 21CFR 820.30.

The phrase "Technical File" is not defined in a regulation or standard and can have many meanings. for example:
Device Master Record (DMR) defined under 21CFR820.181
Medical device file, ISO13485 pt 4.2.3
GHTF STED
MDR..... etc

From your definition,. it sounds like you are referring to the DMR. This should be linked to the batch, so you can identify the version of the DMR in use for any particular batch.
Hello Chris, thank you for your reply. I actually meant MDR technical documentation.
 
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