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Calling organization's products after certified ISO 13485 QMS in place

ISO 13485 & EU MDR
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Guest user Created:   Jun 30, 2021

Calling organization's products after certified ISO 13485 QMS in place

ISO 13485 & EU MDR
With a certified ISO 13485 QMS in place  which is in alignment to national regulatory body as well (though not audited by national regulatory body), can an organization call its products:
  1. GMP grade products or
  2. ISO13485 conforming products or
  3. ISO 13485 and GMP conforming products
Note: I have not used the word compliant for GMP since as I understand that the organization needs to be audited by regulatory body to claim the same?
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Jun 30, 2021

Jun 30, 2021

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