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Documentation of OEM Device - Technical File for a Class IIa Medical Device


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  Post Number #1  
Old 30th September 2009, 05:29 AM
mwa

 
 
Total Posts: 30
Please Help! Documentation of OEM Device - Technical File for a Class IIa Medical Device

All ,


Can anyone give me some advice regarding this .

I am preparing a Technical file for a class II a medical device in EU . We are manufacturing this device in a contract manufacturing facility . So this device is for us a OEM device . This product is not registered by the contract manufacturer. we are going to register it for the first time.

My question , Apart from normal content of technical file , what extra document should i need to have in our technical file regarding this (that the device is manufactured by another medical device facility)?

Thanks for your help in advance

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  Post Number #2  
Old 30th September 2009, 07:41 AM
chris1price

 
 
Total Posts: 178
Re: Documentation of OEM Device

Hi

I would include a flowchart for the manufacturing process and a descrption of the inspection procedures at the sub-contractor and your receiving inspection process.

You may also want to include a copy of your quality plan, agreement or contract with the sub-contractor.

Chris
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  Post Number #3  
Old 30th September 2009, 09:57 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: Documentation of OEM Device - Technical File for a Class IIa Medical Device

You should include more-detailed discussions of any critical material specifications, and any validated processes and critical functional verifications during manufacturing; how the contract manufacturer controls them; and how you control the contract manufacturer.
  Post Number #4  
Old 30th September 2009, 10:53 AM
mwa

 
 
Total Posts: 30
Re: Documentation of OEM Device - Technical File for a Class IIa Medical Device

We haven't performed any validation over there. Is there a special template for the agreement between OEM and PLM ?

Last edited by Stijloor; 30th September 2009 at 02:13 PM. Reason: Typo's.
  Post Number #5  
Old 30th September 2009, 05:25 PM
rthompson

 
 
Total Posts: 20
Re: Documentation of OEM Device - Technical File for a Class IIa Medical Device

If the contract manufacturing facility is ISO certified, I would definitely include that as well under a "Supplier Quality" section of the technical file.
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