Has anybody heard a requirement to be registered to ISO 13485 by the end of 2006? (If you're in the business of medical devices, of course.)
One of my medical device customers told me his registrar was telling him he had to be registered to ISO 13485 by Decembers 2006. I do know they sell their product in Europe and Asia so I don't know if it is a requirement of those countries or not.
Any light shed on the subject would be appreciated.
One of my medical device customers told me his registrar was telling him he had to be registered to ISO 13485 by Decembers 2006. I do know they sell their product in Europe and Asia so I don't know if it is a requirement of those countries or not.
Any light shed on the subject would be appreciated.