Module 15 2022

19/05/2022

Technical equivalence

Actual

Equivalent

?

=

No in-line pressure sensor

In-line pressure sensor

No clinically significant difference in the safety and clinical performance of the device?

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

17

Biological equivalence

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

18

9

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