Module 19 2021

01/06/2021

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 Systematic Approach…

Insight

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

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