Medical devices - “Quality management and clinical validation” (Certificate course)

For (future) experts in regulatory affairs and quality management

Aim and content of the course

The topics of clinical validation and assessment of medical devices as well as quality management issues, including the associated processes, are becoming increasingly important in the field of regulatory affairs. This module provides you with key knowledge and skills in the central methods for this and gives you the opportunity to carry out your own practical project for a selected application.

The practice-oriented module Medical Technology: Quality Management and Clinical Validation imparts and deepens knowledge in the areas of clinical validation and evaluation of medical devices as well as questions of quality management including the associated processes.

Participants learn how to use scientific methods in relation to their own tests, studies and literature analysis. In the area of “Quality & Process Management”, they deal with important organizational processes in a medical technology company as well as the structure and purpose of quality management systems. They also learn how to design operational processes correctly - from the analysis of underlying requirements to their implementation and introduction in the operational environment.

The CAS module concludes with the “Practical Project Quality Management and Clinical Validation”, in which a specific task from the subject area is taken up and worked on by the participants, so that a direct, practical transfer of the knowledge imparted is made possible.

Download file:Medical devices - Quality Management and Clinical Validation CAS flyer

• Clinical evaluation & scientific work
• Quality & process management
• Practical project on quality management and clinical validation

Working methods: Face-to-face seminars and workshops, self-work phases, online coaching

Procedure

The CAS is offered in a blended learning format. This means that it includes blocked attendance days at the Tuttlingen campus as well as self-study phases to prepare and follow up on the content.

It is divided into three individual courses, each of which is completed with a certificate of achievement.

1 semester with four blocked attendance phases at the Tuttlingen campus (2 and 3 days)

Target group

The course is aimed at specialists in the medical technology sector.

Graduates have excellent career prospects in the medical technology industry, in consulting companies, at approved test centers and supervisory authorities. They take on central roles in the areas of product approval, regulatory affairs, quality management and clinical affairs.

Qualification

Academic continuing education certificate from Furtwangen University
Certificate of Advanced Studies (CAS)
(15 ECTS points)

Lecturers

Prof. Dr. Michael D'Agosto
Dean of Studies Medical Technology - Regulatory Affairs, Furtwangen University

Prof. Dr.- Kurt Greinwald
Dean of Studies Medical Technology - Technologies and Development Processes
Dean of Studies Industrial MedTec, Furtwangen University

Prof. Dr. Martin Haimerl
Academic Director Innovation and Research Center Tuttlingen of Furtwangen University (IFC)
Founding representative for the HFU location Tuttlingen

Fees

€3,950.00

The CAS is part of the "Internal link opens in the same window:Medical Devices - Regulatory Affairs" master's degree programme

Registration

The "Medical Technology: Quality Management and Clinical Validation" certificate course is offered every winter semester. As a rule, it consists of four attendance phases on the Tuttlingen Campus (2-3 days each). The exact schedule is available on request. The course will be offered again in winter semester 2025/26.