I need help understanding the terms manufactured by vs. manufactured for vs. manufacturer vs. country of origin. We have devices that are manufactured overseas for us, per our specifications. The device graphic includes our company name. We are ISO13485 certified and the product is subject to the requirements of our quality system (ie. supplier control, incoming inspection, process controls, final inspection, etc.)

Upon receipt, we assemble it with another device and/or package it and ship it.

Since it falls under our quality system requirements, I think we are considered the manufacturer BUT, since more than 50% of the total value is input overseas, they are the country of origin. Right now, our label says manufactured by "Our Company". Is this correct or should it state "Made in XXX for "Our Company"?

Thank you in advance for your help.

Is the overseas product a device that can operate by itself, or is it a component the needs to be assembled with another part to operate?

I've seen some products that say "assembled by Our Company in USA from components manufactured in xxxx."

It is a component that must be assembled with something else to operate BUT...
we sell it as a single component or paired with the other components in an assembled or unassembled state. The other components may or may not be purchased overseas.