Evaluate medical devices and ensure quality
For (future) experts in regulatory affairs and quality management
In the field of regulatory affairs, the topics of clinical validation and evaluation of medical devices as well as issues of quality management, including the associated processes, are becoming increasingly important. This module imparts key knowledge and skills relating to the central methods used in this field and offers participants the opportunity to carry out their own practical project for a selected application.
Learning outcomes and content
The practice-oriented “Medical Technology: Quality Management and Clinical Validation” module imparts and deepens knowledge in the areas of clinical validation and evaluation of medical devices as well as issues of quality management, including the associated processes.
Participants learn how to apply scientific methods in a sound manner in relation to their own tests, studies and literature reviews. In the area of “Quality & Process Management,” they deal with important organisational 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 analysing underlying requirements, to implementing and introducing them in the operational environment.
The CAS module concludes with the “Practical Project: Quality Management and Clinical Validation,” in which participants tackle a specific task from the subject area, enabling them to directly apply the knowledge they have acquired in a practical setting.
Learning objectives
- Clinical evaluation & scientific work
- Quality & process management
- Practical project: Quality management and clinical validation
Part of the MRA programme: the module can be taken individually with a certificate or credited as part of the modular Internal link opens in the same window:Medical Devices - Regulatory Affairs master's programme.
Target group and prerequisites
The programme is aimed at professionals in the medical technology sector.
Graduates have excellent career prospects in the medical technology industry, in consulting firms, at accredited testing laboratories and regulatory authorities. They take on key roles in the areas of product approval, regulatory affairs, quality management and clinical affairs.
Prerequisites
Admission to a contact study programme generally requires a university degree or vocational training in a relevant profession, as well as at least one year of professional experience.
Format
Qualification
Certificate of Advanced Studies (CAS) from Furtwangen University with 15 ECTS credits.
What is a CAS?
A Certificate of Advanced Studies (CAS) is a continuing education qualification offered by universities, primarily in German-speaking countries (e.g., Switzerland, Germany, Austria).
Objective: To deepen knowledge in a specific subject area
Structure: Part of a modular system – several CAS can be combined to form a DAS (Diploma of Advanced Studies) or a master's degree.
Lecturers
Internal link opens in the same window:Prof. Dr. Michael D’Agosto
Dean of Studies, Medical Devices – Regulatory Affairs, Furtwangen University
Internal link opens in the same window:Prof. Dr. Massimo Kubon
Vice-Dean, Marketing & International of Faculty II (Engineering and Technology), Furtwangen University
Internal link opens in the same window:Prof. Dr. Martin Haimerl
Scientific Director, Tuttlingen Innovation and Research Center of Furtwangen University (IFC)
Founding Director of Tuttlingen Campus
Registration
Apply by email at: Email application is started:hfu-akademie[at]hs-furtwangen.de
We require copies of certificates (school/university and professional), as well as a CV and a letter of motivation.
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