CAS HES-SO in Clinical Affairs, Regulatory and Quality for Medical Devices and In-Vitro Diagnostic (CARAQA)

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.

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 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.

Graduates receive a CAS "Certificate of Advanced Studies" worth 15 ECTS, which is recognized by the HES-SO and at European level in accordance with the Bologna Agreements.