Do / update clinical evaluation

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	23.02.2014 09:03:29
Modified:	16.09.2019 16:14:30

Diagram Elements :

Event

Clinical evaluation search terms

Manage clinical study

Product Manager

Assess clinical aspects to be considered

Product (clinical) validation report

CM literature database

Clinical data mart

Assessed clinical data

Clinical literature search report

Clinical evaluation plan

Analysis, merging and conclusion of relevant data

Appraisal of individual data sets

Clinical evalution done

Create clinical evaluation report

Clinical evaluation report

Prepare and apply for clinical study

Identify clinical data

Is clinical evidence sufficient to be able to declare conformity with relevant Essential Requirements?

CA Specialist

Generate clinical evaluation strategy