N
nantmel
Hi all,
This is a debate that I've been having with my boss at the moment... We are an ISO13485 registered company making medical devices for the EU market predominantly. However, we also have a 510K exempt product being sold in America.
We have a 13485 surveillance audit coming up, and there are some discrepancies with the paperwork for the non-CE product headed for the States. My boss argues that it doesn't matter right now as the auditor is only there to audit to CE mark, and can't challenge us on the non-CE product. I am arguing that she has a right to challenge us on all devices we produce, as 13485 is a way of assuring everything under our roof happens according to a set of procedures and controls. Who is right about this?
Secondarily, if I'm right and 13485 does apply to these products, how would a company that manufactures both medical devices and non-medical devices navigate this? Would they have to manufacture them all to 13485 requirements?
Many thanks for your help!
(NB. This is ignoring the fact that we need the paperwork in line to prove GMP for the states too! But with too much work and not enough staff the imminent audit is taking priority)
This is a debate that I've been having with my boss at the moment... We are an ISO13485 registered company making medical devices for the EU market predominantly. However, we also have a 510K exempt product being sold in America.
We have a 13485 surveillance audit coming up, and there are some discrepancies with the paperwork for the non-CE product headed for the States. My boss argues that it doesn't matter right now as the auditor is only there to audit to CE mark, and can't challenge us on the non-CE product. I am arguing that she has a right to challenge us on all devices we produce, as 13485 is a way of assuring everything under our roof happens according to a set of procedures and controls. Who is right about this?
Secondarily, if I'm right and 13485 does apply to these products, how would a company that manufactures both medical devices and non-medical devices navigate this? Would they have to manufacture them all to 13485 requirements?
Many thanks for your help!
(NB. This is ignoring the fact that we need the paperwork in line to prove GMP for the states too! But with too much work and not enough staff the imminent audit is taking priority)