My company's ISO13485 certificate is expiring shortly due to issues with the NB and we may be in a situation where we will not be certified to ISO13485, but the products are CE Marked until 2018.
Can the products still be sold in Europe, while we wait for teh cert to be issued
How does this affect distribution to the US? We are compliant with 21 CFR 820 and have undergone 2 recent FDA audits with no observations.
Can the products still be sold in Europe, while we wait for teh cert to be issued
How does this affect distribution to the US? We are compliant with 21 CFR 820 and have undergone 2 recent FDA audits with no observations.