CAS CARAQA, Hochschule für Life Sciences FHNW

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.

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.

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:

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.