bcsnave

Involved In Discussions
#1
I work at an organization that manufactures Class II medical devices.

We are having debate on where the technical file resides. Engineering or Quality.

The design engineering group submits the devices for listing (60601-1 3rrd ED).

Our engineering manager thinks the technical file resides in quality assurance.

How do other organizations manage this?

Thanks
 

Ajit Basrur

Admin
Staff member
Admin
#2
Re: Which department does the Technical File reside ?

Do you have a Doc Control Center that houses all the organizations's documents?
 

bcsnave

Involved In Discussions
#3
Re: Which department does the Technical File reside ?

Ajit,

Let me clarify.

It is not the physical Repository or location of the file that we are discussing. It is the responsibility for review and compilation of the files.

Our Class II products are evaluated and Reviewed against IEC 60601-1 3rd ED and are submitted to Intertek for evaluation. This is performed when the engineering group designs and gets the ETL listing of the product.

When engineering changes to the device are performed the engineering department is responsible to review the requirements and if needed the device is re-submitted.

So that is what we are in discussion about where the responsibility resides.
 

somashekar

Super Moderator
Staff member
Super Moderator
#4
Re: Which department does the Technical File reside ?

It is the responsibility for review and compilation of the files.
OK.
60601-1 .... Intertek .... ETL mark.
Its clearly the technical stuff and design engineering the owner.
If this is with quality, the process interaction snaps and you are at risk of a NC.
 

sreenu927

Quite Involved in Discussions
#6
Ok. So this technical file is from the Intertek (some call it as Construction File!!).
If this is the case, then what Ajit and Somasekhar suggested is correct.

However, when you say Class II medical device, you (will) also compile a technical file for submission to EU Notified Body for CE Marking. This Technical file (for high risk devices, it is called as Design Dossier) is maintained by regulatory affairs.

Regards,
Sreenu:2cents:
 
H

holgersp

Guest
#7
Hi

In our company it is a the design engineering that own the TF. But QA is according the Design review the approver of the doc.
 

Mikishots

Trusted Information Resource
Trusted
#8
Re: Which department does the Technical File reside ?

Ajit,

Let me clarify.

It is not the physical Repository or location of the file that we are discussing. It is the responsibility for review and compilation of the files.

Our Class II products are evaluated and Reviewed against IEC 60601-1 3rd ED and are submitted to Intertek for evaluation. This is performed when the engineering group designs and gets the ETL listing of the product.

When engineering changes to the device are performed the engineering department is responsible to review the requirements and if needed the device is re-submitted.

So that is what we are in discussion about where the responsibility resides.
You should have been clearer - everything in your OP suggests you're asking about the location of the file, no the responsibility. The documentation is solely the responsibility of Design. It seems very strange that Design would be saying that QA owns the technical files, as this would be saying that Design has nothing to do with the content.
 

evilchilli_420

Inactive Registered Visitor
#9
In my organization and the previous organization I worked with, regulatory affairs maintains ownership of the technical file. Any changes initiated by a cross-functional team is reviewed by RA and QA. The technical file is then updated with the changes. RA is responsible for audits/interaction with notified bodies regarding the technical file updates.

Hope this clarifies.


Thanks,
N
 
A

adlcisa

Guest
#10
Also in my organization RA maintain and update the technical files, then all the changes are approved by RA and QA.
 

Top