We are looking for a Contract Manufacturer

M

MariaHj

Registered
#1
#1
Hi,

We are looking for a contract manufacturer to manufacture a device that will be sold in the U.S, can I ask if the contract manufacturer is required to implement a quality management system according to 21CFR 820 given that we (the legal manufacturer) are 13485:2016 certified, and the device will be manufactured according to our specs.

Thanks
 
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William55401

William55401

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#3
#3
Good answer above. Also suggest that you look at Registration and Listing portion of FDA web site. CM must register and be visible to FDA.
 
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