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Which Department does the Technical File reside?
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Which Department does the Technical File reside?
Which Department does the Technical File reside?
Which Department does the Technical File reside?
Which Department does the Technical File reside?
Which Department does the Technical File reside?
Which Department does the Technical File reside?
Which Department does the Technical File reside?
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Which Department does the Technical File reside?


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Some Related Topic Tags
class ii medical device, european council directive on medical devices, responsibilities, technical files for medical devices
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  Post Number #1  
Old 14th December 2013, 05:15 PM
bcsnave

 
 
Total Posts: 27
Question Which Department does the Technical File reside?

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

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  Post Number #2  
Old 14th December 2013, 05:49 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,169
Re: Which department does the Technical File reside ?

Do you have a Doc Control Center that houses all the organizations's documents?
  Post Number #3  
Old 14th December 2013, 07:57 PM
bcsnave

 
 
Total Posts: 27
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.
  Post Number #4  
Old 14th December 2013, 10:58 PM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,289
Re: Which department does the Technical File reside ?

Quote:
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.
  Post Number #5  
Old 15th December 2013, 10:03 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,169
Look! Re: Which department does the Technical File reside ?

Yes, bcsnave ... the accountability lies with Engineering department.
  Post Number #6  
Old 15th December 2013, 10:18 PM
sreenu927

 
 
Total Posts: 538
Re: Which Department does the Technical File reside?

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
  Post Number #7  
Old 16th December 2013, 08:46 AM
holgersp

 
 
Total Posts: 2
Re: Which Department does the Technical File reside?

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.
  Post Number #8  
Old 16th December 2013, 11:23 AM
Mikishots's Avatar
Mikishots

 
 
Total Posts: 880
Re: Which department does the Technical File reside ?

Quote:
In Reply to Parent Post by bcsnave View Post

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.
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