CAS CARAQA

School of Life Sciences

The CAS Clinicial, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics (CAS European medical device and in-vitro diagnostics regulations have increased complexity for the sector, posing major challenges for clinical, regulatory and quality affairs. Get to know these disciplines, how combine them efficiently, exchange ideas with experts to ensure long-term compliance with product regulations and become a key resource in your company.

Factsheet

Degree: Certificate of Advanced Studies FHNW Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics
Learning environment: Onsite
ECTS points: 13
Next start: 22.9.2026
Teaching languages: English
Venues: FHNW Campus Muttenz, Hofackerstrasse 30, 4132 Muttenz
Fee: CHF 8 800

At a glance

Essential knowledge of clinical affairs, regulatory compliance and quality assurance.
Connect clinical affairs, regulatory and quality assurance – vital for success in modern MedTech environments.
Benefit from a highly interdisciplinary, practice-driven learning experience.
Stay ahead with insights into the latest regulatory and clinical developments.
Develop a broad range of technical and interpersonal skills that equip you to drive your company’s competitive edge and long-term success.
Grow your network by connecting with leading MedTech experts and peers.

Aims and benefits

The CAS CARAQA programme enables you to develop expertise in regulations, clinical affairs and quality assurance while facilitating efficient networking. This is essential for achieving regulatory compliance efficiently and effectively. You are trained to build appropriate communication and cooperation within your organisation and with third parties. The knowledge and skills acquired on the course are essential for ensuring regulatory compliance and product quality, and therefore for fulfilling the role of a Person Responsible for Regulatory Compliance in accordance with Art. 15 of the regulations.

Upon completing this programme, you will be able to:

Demonstrate an in-depth understanding of the European Medical Device Regulation (EU 2017/745) and the In Vitro Diagnostic Medical Device Regulation (EU 2017/746)
Support product development with targeted regulatory and quality expertise, and assure regulatory compliance
Strategically plan and manage necessary action items such as clinical evaluations, ISO 14155 compliant investigations, and IVD performance studies
Communicate effectively with Notified Bodies and National Competent Authorities – even in challenging situations
Lead implementation of ISO 13485 compliant quality management systems
Align supply chain, production and marketing processes with regulatory requirements
Apply expert knowledge such as risk management, biocompatibility, usability and software validation in accordance with current standards

You will complete the continuing education programme by writing a thesis on a topic of your choice. This will enable you to apply your knowledge directly to your professional setting.

Target audience

This part-time continuing education programme is designed for you as a professional working throughout the life cycle of medical devices and in vitro diagnostic devices, from suppliers and manufacturers to distributors.

This programme provides the knowledge and insights you need, whether you work in regulatory or clinical affairs, manage quality assurance, or support market approval processes. It is equally suited to developers, production and manufacturing specialists, as well as physicians, scientists and inventors who are advancing MedTech innovations. If you conduct clinical studies or hold a regulatory or quality role in a healthcare facility, this programme will give you the confidence to navigate the evolving landscape.

During my studies, I became aware of how important Regulatory Affairs are for medical device manufacturers and how they drive innovation. Attending the programme was a huge opportunity for me! Ultimately it enabled me to specialize in my area of interest and develop my career in the direction I wanted. I remember the many lively and fruitful discussions I had with my inspiring classmates and lecturers. I really appreciate the people I had the chance to meet in this programme and I am still in contact with many of them.

Alba Gutiérrez, Senior Associate

It was fascinating to get first-hand insights into the uncertainty in the medtech sector. It became clear that although the pharmaceutical industry and the medical technology sector have the same goals - always with a focus on patient safety – there are nevertheless different approaches in some areas. As part of my continuing education, I learned how quality is ensured during medical technology product development. The programme offers an ideal combination of project and quality management, especially for those who want to acquire broad expertise in medical technology. It was particularly valuable to have the chance to deal in depth with a topic of my own choosing as part of the final thesis. The face-to-face discussions with my supervisor also greatly enriched the programme.

Dennis Wald, Head of Qualification and Validation

The main topics of clinical affairs, regulatory affairs and quality assurance for medical devices & in-vitro diagnostics were presented in an exciting and multifaceted way. It was great to have so many different lecturers who have all had profound experience in the industry. I also found it very helpful that we had interactive exercises on each day of the course, where we could directly apply and try out the things we had learned. In addition, the class size of around 15 people was perfect, as was the fact that the participants had such a variety of backgrounds. This made it possible to learn from each other in the exercises and discussions, and to get an insight into how problems are solved in other companies. For these reasons, I can strongly recommend the CAS CARAQA programme to anyone who is active in this field.

Alain Dietschy, Quality Manager

Structure and programme contents

This part-time programme covers three main pillars. Through focused modules, you will gain in-depth knowledge, learn best practices from our experts and develop practical skills that you can apply directly to your professional context.

The CAS reflects the high complexity and integration of regulatory affairs, quality assurance and clinical affairs. These form the core of the programme, with an in-depth exploration of the individual domains and their interconnections. Thanks to the close involvement of industry experts, the curriculum is continuously updated and guided by real-world practice.

First you will receive an introduction to MedTech products and their markets, as well as a comprehensive overview of European and foreign regulations. You will also gain an in-depth understanding of the key stakeholders, such as notified bodies and competent authorities. Building on this foundation, the program focuses on the following key areas:

Module 1: Regulatory Affairs

In-depth training in the European Medical Device Regulation (EU 2017/745) and In Vitro Diagnostic Medical Devices Regulation (EU 2017/746)
Procedures and market access pathways in other global markets, such as the US (FDA), China, Canada, Australia, the UK and the ASEAN countries
Special features of the Swiss market
Technical expertise in critical domains such as:

risk management (ISO 14971)
electrical safety and electromagnetic compatibility (IEC 60601)
biocompatibility (ISO 10993-1)
usability (ISO 62366)
software management (IEC 62304)

Impact of other European regulations on medical device development: The Cybersecurity Act, the European Artificial Intelligence Act, and the General Data Protection Regulation
Creation and organisation of technical documentation for national and international markets
Advanced communication strategies for effective interaction with Notified Bodies and National Competent Authorities, including crisis management skills

Module 2: Quality Assurance

Requirements for documentation, management, resources and development for a compliant quality management system – insights into ISO 13485
Structures and system organisation to ensure an efficient quality system
Leadership in the deployment and maintenance of Quality Management Systems aligned with ISO 13485 and US QSR requirements
FDA audits and the Medical Device Single Audit Programme MDSAP

Module 3: Clinical Affairs

Clinical evaluation of medical devices and in-vitro diagnostics
Strategic planning and management of clinical evaluations, investigations and performance studies in accordance with ISO 14155 and current IVD standards
Monitoring the performance, safety and effectiveness of medical devices and in-vitro diagnostic medical devices: Post Market Surveillance (PMS), including Post-Market Clinical Follow-up (PMCF) and Performance Follow-up (PMPF)
Executing downstream quality management activities, fulfilling manufacturers' reporting obligations and integrating new insights into continuous risk management.

Requirements and admission

At least one of the following admission requirements must be met:

Tertiary educational qualification (at least Bachelor’s degree level) and relevant professional experience.
Federal Diploma of Higher Education (from a Swiss “Höhere Fachschule” or “eidg. HFP” or “eidg. BP”) and at least 3 years’ professional experience in a subject relevant to the programme.
At least 5 years’ professional experience in a subject relevant to the programme and successful completion of continuing education courses (in-company or CAS/MAS/DAS), or partially completed tertiary education (> 50%).

As the instruction and educational materials are in English, proficiency in English (minimum level C1) is a prerequisite.

Organisational matters

Format

The lessons are taught on Tuesdays at the FHNW campus in Muttenz (Switzerland). The course ends with an examination, and the completion and defence of a small final project.

Programme partner

The programme is offered with our partner Veranex and is part of the European CARAQA network. Veranex is the only comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. They offer expert guidance from concept through to commercialisation, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance.

Veranex partners the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.

Downloads

Programme specific

General Documents

All general documents can be found here.

Advice and information events

Contact

Prof. Dr. David Hradetzky

Deputy head of institute and lecturer Dean of Master in Biomedical Engineering

Phone: +41 61 228 54 58
E-Mail: david.hradetzky@fhnw.ch

CAS CARAQA, FHNW School of Life Sciences