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

By Niamh Miller and Laura Taylor2023-02-07T09:25:00

Source: Adobe Stock

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.

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