B
B Gridack
Hello All:
My name is Paige Gridack and I am Document Control for a medical device company located in southern California. We may be changing physical locations soon. We are currently ISO 13485 certified & some of our products are CE marked.
From what I can glean from other threads, I will need to change our address with our Notified Body and on our certificate.
However I am looking for information on the following:
1. Are there any change of location requirements for ISO 13485? My supervisor mentioned something about a possible inspection, but I believe that is only for manufacturing on site, which we do not do.
2. What, besides contacting our Notified Body & changing the Certificate, do I need to do to update our CE Certification?
3. What are the USA federal requirements for a change of address? I understand we will have to update the address, but are there any possible inspections?
4. Finally, what are the California state regulations regarding a change of address? This is probably the most difficult.
I am in the process of researching all of these answers independently, but the collective intelligence would be greatly appreciated.
Thank you!
My name is Paige Gridack and I am Document Control for a medical device company located in southern California. We may be changing physical locations soon. We are currently ISO 13485 certified & some of our products are CE marked.
From what I can glean from other threads, I will need to change our address with our Notified Body and on our certificate.
However I am looking for information on the following:
1. Are there any change of location requirements for ISO 13485? My supervisor mentioned something about a possible inspection, but I believe that is only for manufacturing on site, which we do not do.
2. What, besides contacting our Notified Body & changing the Certificate, do I need to do to update our CE Certification?
3. What are the USA federal requirements for a change of address? I understand we will have to update the address, but are there any possible inspections?
4. Finally, what are the California state regulations regarding a change of address? This is probably the most difficult.
I am in the process of researching all of these answers independently, but the collective intelligence would be greatly appreciated.
Thank you!