Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

ISO13485:2016

 ISO13485:2016 is still the standard of choice under IVD Regulation

• Is specific for the In Vitro Medical Device and Medical Device industry • Not yet harmonized under IVDR • Concept of QMS has been extended to economic operators • Requirement for a QMS is included in the conformity assessment annexes IX, X and XI

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The Organisation for Professionals in Regulatory Affairs

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Insight

“Understanding your inputs and outputs are essential for effective Quality Management. The processes within ISO13485 are interconnected and work collectively to ensure quality.”

The Organisation for Professionals in Regulatory Affairs

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