Module 15 2022

19/05/2022

Generate clinical data

MDR Annex XIV1(d):

“generate, through properly designed clinical investigations in accordance with the clinical development plan, any new or additional clinical data necessary to address outstanding issues”

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

35

Clinical Evaluation – Analyse the clinical data

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

36

18