Class II Medical Device Technical File Checklist

[Christopher01]

I am nearly complete compiling my medical device class IIb employer’s Technical File based on the MDD, several guidance documents, and the Preparation of a Technical File procedure available on Elsmar Cove Forum. The Preparation of a Technical File procedure is proving very helpful in developing the required Technical File Preparation and Maintenance work instruction. Unfortunately, the referenced Technical File Checklist was not included and I am configuring my own.
I would really appreciate one of my Quality colleague’s help steering me to, or providing me a sample Technical File Checklist to evaluate. Also, if possible I would welcome/ appreciate the opportunity to review another sample Preparation of a Technical File procedure.

Thank you very much,
Chris

 

[Ronen E]

I am nearly complete compiling my medical device class IIb employer’s Technical File based on the MDD, several guidance documents, and the Preparation of a Technical File procedure available on Elsmar Cove Forum. The Preparation of a Technical File procedure is proving very helpful in developing the required Technical File Preparation and Maintenance work instruction. Unfortunately, the referenced Technical File Checklist was not included and I am configuring my own.
I would really appreciate one of my Quality colleague’s help steering me to, or providing me a sample Technical File Checklist to evaluate. Also, if possible I would welcome/ appreciate the opportunity to review another sample Preparation of a Technical File procedure.

Thank you very much,
Chris

Hello and welcome to the cove

Checklist - Annex VII of the MDD provides a list of items that should be included. I find it sufficient in most cases.

Cheers,
Ronen.

 

[somashekar]

I am nearly complete compiling my medical device class IIb employer’s Technical File based on the MDD, several guidance documents, and the Preparation of a Technical File procedure available on Elsmar Cove Forum. The Preparation of a Technical File procedure is proving very helpful in developing the required Technical File Preparation and Maintenance work instruction. Unfortunately, the referenced Technical File Checklist was not included and I am configuring my own.
I would really appreciate one of my Quality colleague’s help steering me to, or providing me a sample Technical File Checklist to evaluate. Also, if possible I would welcome/ appreciate the opportunity to review another sample Preparation of a Technical File procedure.

Thank you very much,
Chris

Hi Christopher ...
A very warm welcome to you into the cove.
Hope this can give you some directions further ~~~

 

[bio_subbu]

Hi Chris

Welcome to the Cove..

Please refer attached Notified Body guidance document on "Technical Documentation (NB-MED/2.5.1/Rec5)"

Regards
S. Subramaniam

 

[Christopher01]

Hi Subbu,

Thank you for proving me the "Technical Documentation (NB-MED/2.5.1/Rec5)". I have been using it from the start and it has proven very helpful.
In the meanwhile I remained on the hook for a sample Technical File Checklist until this afternoon. Another Quality colleague very kindly provided me a sample TCF Contents List. I am currently comparing my nearly complete Technical File Checklist with the sample list.
I would still welcome/ appreciate a sample Technical File Preparation and Maintenance procedure or work instruction to review from one of our Quality colleagues. My work instruction is in pretty good shape but, I would like to compare my work instruction with a proven/ notified Body accepted process.

Regards,
Chris

 

[sagai]

mmantunes used to submit a comparison list for TF somewhere in this cove, I can not recall exactly where to.
br
Sz.

 

[SteveK]

Hi Chris,

Although this is not a WI, the attachment is the first three pages of my (electronic) TF and how I structure it. This may be of help. I have submitted a TF to a NB with this structure and they approved it.

Steve

 

[Christopher01]

Hi Steve,

Thank you for sharing your technical file format approved by a notified body.


Chris

 

[quest]

We are being told by our notified body that we must include in our tech file, a product history that must include 510(k) and PMA clearances. Any idea why a notified body would require this information be maintained in a tech file?

 

[sagai]

what??!!

Strange request, I think.


Sz.