Hi All, help please., thank you.
I am aware of the reporting criteria for FSCAs but are there any requirement for manufacturer Field Corrective Actions (FCAs) to be reported to NCAs as well?
A notified body for a client seems to think it is a requirement for the EU.
Thank you for any feedback!
I am aware of the reporting criteria for FSCAs but are there any requirement for manufacturer Field Corrective Actions (FCAs) to be reported to NCAs as well?
A notified body for a client seems to think it is a requirement for the EU.
Thank you for any feedback!