L
Hi there,
Firstly thank you to all the posters on this site, you have all been very helpful!
A little about us and our device... We are a small company with a product that we will be selling worldwide. It is a Class I medical device (in Europe, and Class II in the US)
We are CE marked and operating out of Europe.
We have created labelling documents in order to obtain our CE mark as well as the FDA has approved our Labelling section for our 510(k) application.
My questions is, do we need to create an SOP for labelling now as we move toward obtaining our ISO 13485 certification?
If so, does anyone have a template I could follow?
Many thanks in advance for your input!
Cheers,
L
Firstly thank you to all the posters on this site, you have all been very helpful!
A little about us and our device... We are a small company with a product that we will be selling worldwide. It is a Class I medical device (in Europe, and Class II in the US)
We are CE marked and operating out of Europe.
We have created labelling documents in order to obtain our CE mark as well as the FDA has approved our Labelling section for our 510(k) application.
My questions is, do we need to create an SOP for labelling now as we move toward obtaining our ISO 13485 certification?
If so, does anyone have a template I could follow?
Many thanks in advance for your input!
Cheers,
L