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CAS CARAQA

Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics

Key data

Degree: Certificate of Advanced Studies FHNW Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics
ECTS points: 13
Next start: 7.01.2025
Final application date: Mon, 25.11.2024
Teaching language: English
Place: Muttenz
Fee: CHF 8’800

The European market for medical devices and in-vitro diagnostics, the second largest such market in the world, is undergoing a significant evolution with the implementation of the new Medical Device Regulation (EU 2017/745) and In-Vitro Diagnostics Regulation (EU 2017/746). Compared to the EU Directives, the Regulations have expanded the requirements for achieving a high level of medical device safety and performance in Europe. To satisfy these requirements, the demand for regulatory, quality and clinical affairs professionals throughout Europe has increased significantly. In addition, medical device and in vitro diagnostics manufacturers located in Switzerland face even more challenges. Due to the outdated Mutual Recognition Agreement, Swiss companies are in effect from a third party country when entering the European market, creating additional burdens. Meanwhile, countries in the Gulf, Asia and South America have introduced requirements that are at least as complex as those in Europe or the US. As a result, exporting to all these regions is a major challenge for Swiss firms.

This programme is designed for regulatory, clinical and quality professionals in the European medical devices and in vitro diagnostics sectors. Our education programme provides participants with advanced knowledge, hands-on experience and first-hand skills from industry experts. The structure of the programme enables participants to assume responsibility within their organisation for regulatory compliance (PRRC) in accordance with Art. 15 MDR and IVDR. This will enable professionals to make key organisational decisions and play a vital role in maintaining the competitiveness and longevity of the business. The programme provides an in-depth insight into regulatory, clinical and quality management issues and emphasises the application of this knowledge in a practical professional context.

CAS CARAQA in Muttenz is part of the European CARAQA network. To date, more than 190 participants have successfully completed CARAQA in Muttenz, Yverdon-Les-Bains, Lubeck and Louvain-La-Neuve in Belgium.

Content

The CARAQA training is structured around three areas: Clinical Affairs, Regulatory Affairs and Quality Assurance - CA/RA/QA. Understanding and connecting these is essential for professionals in the field. As this landscape is still very dynamic and the requirements set by the European Commission are constantly evolving, the content of the program will be continuously adapted to reflect the current needs and challenges of the medical device and in vitro diagnostics industry.

The CAS CARAQA begins with a comprehensive introduction to the world of medical devices and in-vitro diagnostics, providing participants with a solid understanding of the MedTech environment, product lifecycles and effective interaction with the stakeholders involved.

Regulatory Affairs covers the management, implementation and application of regulations, standards and guidance documents. It covers the essential practices of integrating regulatory requirements into product design and lifecycle, ensuring that the content and structure of technical documentation meet regulatory requirements, and the implementation and application of risk management. While the main focus will be on the European market, other regulations such as for the US, Canada, Asia will be introduced.

Quality Management covers the structure of a quality management system, managing its documentation, and critical quality processes such as audits, improvements and changes. Special attention is given to ISO 13485 Quality Management for Medical Devices, US CFR21 820 and the MDSAP programme.

Clinical Affairs includes the structure and management of clinical or performance evaluations, the organisation of clinical investigations, aspects of clinical trials and their design strategies, and the conduct of literature reviews. Post market activities such as Post Market Surveillance (PMS) or Post Market Clinical Follow-up (PMCF) are covered in this section.

With hot topics affecting the world of medical devices and in vitro diagnostics, such as artificial intelligence or the General Data Protection Regulation (GDPR), the programme is constantly being revised and adapted. The course is designed to equip you to deal comprehensively with all facets of medical devices and in vitro diagnostics.

Overview

The programme is aimed at people in medical device and in vitro medical device companies and suppliers who are directly or indirectly facing challenges in a CA/RA/QA environment. Individuals wishing to develop their skills in this direction are also very welcome.

Employees in the regulatory, clinical and/or quality assurance department
Engineers from electronics, mechanical or software disciplines, in charge of medical device or in-vitro medical device projects
Experts in manufacturing and production
Physicians, scientists or inventors of medical products
Employees involved in clinical studies or quality/regulatory processes in healthcare organisations

Tertiary educational qualification (at least Bachelor degree level) and relevant professional experience or Federal Diploma of Higher Education (from a Swiss “Höhere Fachschule” or “eidg. HFP” or “eidg. BP”), and at least 3 years of relevant professional experience in a subject relevant to or related to the continuing training programme.
Interested persons without tertiary educational qualification can be admitted, if they have a minimum of 5 years professional experience in a subject relevant to or related to the continuing education programme and if they have successful completed various continuing training courses (in-company or CAS/MAS/DAS) or discontinuation of tertiary education with advanced participation or partial achievement (> 50%)

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

The programme is tailored to equip participants with the essential skills required by the medical device and in vitro diagnostics industries. With the evolving dynamics of CA/RA/QA roles, our aim is to cultivate a diverse set of technical and interpersonal skills. These will prepare participants to progress to decision-making positions within their organisations and play a pivotal role in maintaining the company's competitive edge and long-term viability.

The CAS CARAQA develops the following skills:

Optimal preparation for regulation according to MDR 2017/745 and IVDR 2017/746
Strategic planning and management of clinical evaluations, investigations in accordance with ISO 14155 and performance studies of IVDs
Strategic and tactical communications for interactions with Notified Bodies and National Competent Authorities, as well as crisis management
Management and technical support for new product development projects
Leadership in implementing and maintaining ISO 13485 and US QSR quality management systems
Structuring of supply chain, production and marketing
Technical expertise in key subjects such as risk management, biocompatibility, usability and software validation, according to current standards

The programme runs annually starting in the calendar week 2. It takes place at the FHNW School of Life Sciences, Campus Muttenz. Lessons are every Tuesday, with a break at Easter, and last until week 27.

The programme ends with a final written exam and the writing and presentation of an individual thesis. The subject of the thesis is a complete CA/RA/QA study of a medical device or IVD device according to guidelines set out in the programme. The device can be chosen individually by each participant and can be related to his/her professional activities. The thesis is written in English.

Veranex is the only comprehensive, global, techenabled service provider dedicated to the medical technology industry. They offer expert guidance from concept through to commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance. Veranex enables accelerated speed to market, controlled development costs, development risk mitigation and rapid market viability assessment. Veranex partners the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments in order to advance patient care.

Contact

Head of Programme

Prof. Dr. David Hradetzky
T +41 61 228 54 58
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Dr. Elena Lucano
T +41 76 270 37 51
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Programme Administration

Zuzana Tumova
T +41 21 311 20 59
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Elzbieta Lehmann
T +41 61 228 55 40
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Graduates tell us

“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 Further testimonials