C
I?m am wondering if it makes a difference if there is a written contract between the two entities. Furthermore is that contract what makes them an official Contract Manufacturer?
This statement is found in the link under Contract Manufacturer.
A person(s) that manufactures a finished device under the terms of a contract with another manufacturer is a contract manufacturer. The agreement between the manufacturers should be documented in a written contract.
http://www.fda.gov/MedicalDevices/D...dicalDeviceQualitySystemsManual/ucm122391.htm
This statement is found in the link under Contract Manufacturer.
A person(s) that manufactures a finished device under the terms of a contract with another manufacturer is a contract manufacturer. The agreement between the manufacturers should be documented in a written contract.
http://www.fda.gov/MedicalDevices/D...dicalDeviceQualitySystemsManual/ucm122391.htm