Any recommendations for Own Brand Labelling notified bodies for medical devices?
Can the OBL audit be performed offsite with the transfer of files ?
I appreciate any help.
A good approach is to work with the same NB as of the original manufacturer, however this is not a requirement. If you have your own NB for your other products, then they can help you and they will bank on the original manufacturer's NB certificate, with an offsite audit of required OBL systems documentation that you make and provide, including your draft DOC. We have successfully done this in both the above said scenario and offsite.
The ZLG document about OBL is a good lead. NB's who have performed OBL CE have also drafted their own guidelines for clients help.
If you wish to, ask UL (no affiliations) in your region.