Hi,
We are medical device manufacturers manufacturing equipment and orthopedic implants. In USFDA CE or ISO 13485 is there any clause or requirement that states that raw material suppliers have to be ISO 13485 certified especially for high risk devices . Suppose that the raw material supplier is certified to ISO 9001 and all lots supplied are tested to relevant ISO standards for chemical , physical and mechanical properties is it not ok?
Does ISO 13485 require suppliers to be ISO 13485 certified ?
Please comment
Thanks
michelle
We are medical device manufacturers manufacturing equipment and orthopedic implants. In USFDA CE or ISO 13485 is there any clause or requirement that states that raw material suppliers have to be ISO 13485 certified especially for high risk devices . Suppose that the raw material supplier is certified to ISO 9001 and all lots supplied are tested to relevant ISO standards for chemical , physical and mechanical properties is it not ok?
Does ISO 13485 require suppliers to be ISO 13485 certified ?
Please comment
Thanks
michelle
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