Medical devices - Regulatory Affairs and Development Management fundamentals ( Certificate course)

For (future) experts in regulatory affairs, risk and development management

Aim and content of the course

The Medical Technology: Fundamentals of Regulatory Affairs and Development Management module provides a solid foundation for working in the field of regulatory affairs. It consists of two courses and an individual practical project. The course lasts one semester (usually from March to July) and is divided into four attendance phases (2-3 days).

The subject “Introduction to Regulatory Affairs” deals with the legal foundations and their implementation in operational processes.

Topics include:

• Intended purpose
• Conformity assessment
• Standards
• Notified body
• Authorities and economic operators in the EU Medical Device Regulation (MDR).

Participants will be able to prepare the technical documentation required for approval.

The subject “Development and Risk Management” delves deeper into the central questions of how the development of a medical device should be implemented with regard to regulatory issues. This includes the life cycle of a medical device, development processes and control, project management methods as well as innovation management and labeling. Another major topic area is the consideration of risk management and usability in medical device approval, including principles, strategies and methods. The focus here is on practical implementation in specific application scenarios.

This approach culminates in the Regulatory Requirements practical project, in which participants are given the opportunity to work on a specific task from the fields of regulatory affairs and development management and thus deepen their skills in a practical way.

Learning objectives

• Introduction to regulatory affairs
• Development and risk management
• Regulatory requirements practical project

Working methods: Classroom seminars and workshops, self-study phases, online coaching

CAS flyer Medical Technology: Fundamentals of Regulatory Affairs and Development Management

Procedure

The subject “Development and Risk Management” delves deeper into the central issues, such as the development of a medical device with regard to

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

Scientific 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. Mike Fornefett
Professor of Medical Device Technology, Furtwangen University

and other lecturers from professional practice

Fees

€3,950.00

The CAS is part of the "Medical Technology - Regulatory Affairs" master's degree programme

Registration

The "Medical Technology: Quality Management and Clinical Validation" certificate course is offered every summer 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 is currently being offered in summer semester 2025.