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Free online course 

mini course: clinical evaluation

Requirements & basics

Hi, my name is Nadine Leistner and I am glad you are here!

You want to know what a Clinical Evaluation for Medical Devices is?

Are you a Regulatory Affairs Manager and would like an up-to-date overview of the requirements for Clinical Evaluation?

You would like to change or develop your career in the field of medical writing for medical devices?

......Then this mini-course is a good start!


You will get all the basic information about the requirements of Clinical Evaluation in the approval process of medical devices. You will learn which regulatory requirements and standards are relevant for the preparation of the Clinical Evaluation. By describing the basic processes of clinical evaluation, you will gain an insight into how clinical evaluation is carried out. In addition, you will get an overview of the required documents and the related documents including the PMCF & PMS plans.

What you will learn in this course:


You will learn what role the clinical evaluation has in CE approval.
You will learn which legal texts and guidelines are relevant for the preparation of a clinical evaluation.
You will learn how a clinical evaluation is structured.

You will learn what to do in a clinical evaluation.
You will learn which documents the clinical evaluation is made up of.
You will learn which other documents are important for the preparation of the clinical evaluation.


In a nutshell: you will get an all-round view of clinical evaluation according to MDR

At the end of the workshop...

You will understand how a clinical evaluation works and what is important in its preparation.
You will understand which documents are important for the preparation of the clinical evaluation. 
You will know where to find all the information you need for the clinical evaluation.