Requirements for Site Registration for Medical Devices

N

nadavreu

Hi all
We are a aseptic filling manufacture specializes in cell culture products and we currently in process of submitting 510(k) for one of our products.

We are debating whether we need to make changes to the production site or any facility adjustments?! :argue:

Can someone refer me to the requirements for site registration for Medical Device? :rolleyes:

Thanks
nadav
 
Top Bottom