Hi All,
I noticed the following in GD 210 of Health Canada Guidance Document:
So this means, while performing Internal Quality audit, we should not mention the MDR requirements are NOT met. We should only reference the ISO 13485 Clauses.
Would anyone confirm the above?
Thanks,
Sreenu
I noticed the following in GD 210 of Health Canada Guidance Document:
2.3.3 Nonconformities
All nonconformities shall be reported directly against a requirement of ISO 13485:2003 and
never directly against a section of the MDR.So this means, while performing Internal Quality audit, we should not mention the MDR requirements are NOT met. We should only reference the ISO 13485 Clauses.
Would anyone confirm the above?
Thanks,
Sreenu