Niamh Miller

Niamh Miller is a Regulatory Affairs Consultant at Real Regulatory Ltd.

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    Successful transition of your ISO 13485 QMS from MDD/IVDD to MDR/IVDR


    The new requirements in the MDR/IVDR will affect the QMS of medical device manufacturers, however, use of the ISO 13485 standard is a useful starting point in meeting many of these requirements. The use of a gap analysis, project implementation plan, and ISO 13485 provide an approach that will allow manufacturers to successfully transition from MDD/IVDD to MDR/IVDR.