C
Morning Covers,
We are a company who Own brand label Class IIa devices. We do this by sending our branding to the OEM who then incorporate into their design and we buy the finished product.
We have a NB audit due in June 2013. If we discontinued stock and allowed to sale through prior to June 2013 (no more stock purchased), in your opinion would a NB audit still be required?
I understand that under the directives (93/42/EEC and 2007/47/EC) we still have a regulatory obligation to continue with PMS, Vigilance reporting and the retention of records/documents and we will continue to do this.
Can anyone shed any light on this issue before we speak to the NB themselves?
Thanks in advance.
Claire
P.S. Have a great festive period everyone!!
We are a company who Own brand label Class IIa devices. We do this by sending our branding to the OEM who then incorporate into their design and we buy the finished product.
We have a NB audit due in June 2013. If we discontinued stock and allowed to sale through prior to June 2013 (no more stock purchased), in your opinion would a NB audit still be required?
I understand that under the directives (93/42/EEC and 2007/47/EC) we still have a regulatory obligation to continue with PMS, Vigilance reporting and the retention of records/documents and we will continue to do this.
Can anyone shed any light on this issue before we speak to the NB themselves?
Thanks in advance.
Claire
P.S. Have a great festive period everyone!!
