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

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

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.

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

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