We manufacture nurse call pillow speakers and sell them to our distributor (with their name on our device). We are FDA registered and certified to 13485.
Our distributor was recently audited by their registrar (against 13485:2016) and received a nonconformance because they did not have any DHRs for the pillow speaker we sold them.
They indicated that they will be requiring our DHR(s) for every batch we sell them.
I'm unclear as to the requirement under 4.2.3. for a distributor. Can anyone provide some guidance?
Thanks,
Michelle
Our distributor was recently audited by their registrar (against 13485:2016) and received a nonconformance because they did not have any DHRs for the pillow speaker we sold them.
They indicated that they will be requiring our DHR(s) for every batch we sell them.
I'm unclear as to the requirement under 4.2.3. for a distributor. Can anyone provide some guidance?
Thanks,
Michelle
