Q
I work for an IOL company that manufactures its devices outside the US.. These devices have an approved PMA and we now distribute them from our US headquarters (where I work) The US office is also listed as an alternate manufactuer of these same devices.
I believe we have to maintain distribution records to the final distributor on site here.....others disagree. IOLs are no longer considered to have tracking requirements. We are also ISO 13485 certified.
Help me to decide if we need to keep records here or can we send them to manufacture not in US? Or can we scan these records into a PDF format without worrying about part 11 compliance.
I believe we have to maintain distribution records to the final distributor on site here.....others disagree. IOLs are no longer considered to have tracking requirements. We are also ISO 13485 certified.
Help me to decide if we need to keep records here or can we send them to manufacture not in US? Or can we scan these records into a PDF format without worrying about part 11 compliance.