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Implant Raw Material Supplied from Customer to Contract Manufacturer

I

Ironcountry

#1
Hello All,

Re: Implant raw material is provided from customer to supplier for machining and then that device is sent back to the customer, what is the best practice with regard to including material certs. with the implant material (customer to supplier)? If certs are not provided, then the suppliers DHR is incomplete correct? Traceability is still maintained through batch number tracking but it would appear logical to include the raw material certifications.

I'd like to know other companies policies and experiences.
 
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Mikishots

Trusted Information Resource
#2
Hello All,

Re: Implant raw material is provided from customer to supplier for machining and then that device is sent back to the customer, what is the best practice with regard to including material certs. with the implant material (customer to supplier)? If certs are not provided, then the suppliers DHR is incomplete correct? Traceability is still maintained through batch number tracking but it would appear logical to include the raw material certifications.

I'd like to know other companies policies and experiences.
If the customer is expecting that the material in the finished part conforms to requirements, they'd be responsible for determining this prior to delivery to the supplier.

Depends on the contract as well; I have been involved with companies using this scenario, and have seen contracts that state something like "In cases where raw material is provided directly to the subcontractor by X, the subcontractor shall utilize the material as-is; verification of certification or approvals of the supplied raw material shall be the responsibility of X".
 
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