In truth, technically only Canada is “demanding” ISO 13485. CE Marking presumes compliance with the directives when you are ISO 13485 Qualified, but it’s not required. I hope this aids. Before you can find Licensed, you might first really need to create and doc your creation processes, applying the http://edwinvvzcu.mpeblog.com/12915535/iso-registration-process-no-further-a-mystery