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MDDRegAffairs
Dear all,
I was recently informed by our ISO 13485, and ISO 14971 auditor, Intertek, that they no longer certify ISO 14971. Their justification is that 14971 certification is not required for MDD, FDA, or Health Canada, only compliance is required.
We are a U.S. based company. Our 3 year audit is scheduled for May 2015.
Can anyone comment on this? Should we find another auditor? What concerns are there for being compliant and not certified (other than all the paper work where 14971 certification is claimed)?
Any thoughts, comments, or suggestions would be greatly appreciated.
Kind Regards,
MDDRegAffairs
I was recently informed by our ISO 13485, and ISO 14971 auditor, Intertek, that they no longer certify ISO 14971. Their justification is that 14971 certification is not required for MDD, FDA, or Health Canada, only compliance is required.
We are a U.S. based company. Our 3 year audit is scheduled for May 2015.
Can anyone comment on this? Should we find another auditor? What concerns are there for being compliant and not certified (other than all the paper work where 14971 certification is claimed)?
Any thoughts, comments, or suggestions would be greatly appreciated.
Kind Regards,
MDDRegAffairs
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