Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Medical Device Single Audit Programme • Demonstrate conformity of Quality Management Systems • Based on ISO13485:2016 • Essential for Canadian registration • Supports Japan, Australia, USA and Brazil registration

Insight

“Good example of global harmonisation approach, this is highly recommend is these markets are required as part of the portfolio. There is an additional cost for this service will allow less audit pressure and ease market access routes”

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes: Recap

 Quality Management Systems are essential for the IVD industry  How a QMS is used is highly dependent on the organisation, but based on ISO13485 requirements  An effective QMS can add real value  MDSAP is a useful addition to the process if applicable to your product portfolio

The Organisation for Professionals in Regulatory Affairs

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