Medical Devices: Fundamentals of Regulatory Affairs and Development Management

The “Introduction to Regulatory Affairs” programme covers the legal basis and its implementation in operational processes.

Topics include:

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

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

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

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

Learning objectives

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

Part of the MRA programme: The module can be taken individually with a certificate or used as an introduction to the modular Internal link opens in the same window:Medical Devices - Regulatory Affairs master's programme.

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 at 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.

The CAS is offered in a blended learning format. It includes block attendance days at the Tuttlingen campus as well as self-study phases for preparation and follow-up work on the content.

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 professional development 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.

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. Mike Fornefett
Professor of medical instrument technology, Furtwangen University

as well as other lecturers from professional practice

Register by email at: 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.