CAS CARAQA (Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics)

The CAS CARAQA is divided into the three specialist disciplines of Regulatory, Quality Assurance and Clinical Affairs. All three are currently very dynamic, particularly in Europe, so the programme and content are constantly updated and adapted to current developments. This is ensured by the involvement of proven experts from the field, whose experience is incorporated into the training in addition to the practical elements. On-site events give participants the opportunity to make valuable contacts and network with other industry experts.

At the beginning of the programme, participants receive an introduction to MedTech products and their market, a comprehensive overview of European regulations, and a detailed look at the players involved such as notified bodies and competent authorities.

The area of regulatory affairs includes in-depth insights into the European Medical Device Regulation (EU 2017/745) and In-vitro Diagnostic Medical Device Regulation (EU 2017/746), supplemented by corresponding publications of the Medical Device Coordination Group (MDCG guidance). It also examines the approval process for the US market (FDA) and procedures in other global markets such as China, Australia, Canada, the UK and the Association of Southeast Asian Nations (ASEAN). Special features of the Swiss market are also covered.

Content such as MDR and IVDR classification, risk management (ISO 14971), electrical safety and electromagnetic compatibility (IEC 60601), biocompatibility (ISO 10993-1) and usability (ISO 62366) requirements are examined in detail. Obligations resulting from increasing digitalization, such as the Cybersecurity Act, the European Artificial Intelligence Act or the General Data Protection Regulation, are also taken into account. These are accompanied by input on the creation and organisation of technical documentation required for European and international markets.

Putting regulatory requirements into practice needs an efficient, compliant quality management system. The programme introduces suitable structures and system organisation, goes into detail on ISO 13485 and discusses implementation options. In addition to European requirements, those for the global market (US 21 CFR part 820, MDSAP) are also addressed.

Another key part of the programme is training in clinical evaluation, medical device testing and in-vitro diagnostics. Participants learn the latest strategies and organizational techniques for clinical trials, and gain insights into Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF). Also highlighted are implementation of these downstream quality management activities, manufacturers’ reporting obligations and the integration of new findings into risk management.

The course ends with an examination, and the completion and defence of a small final project.

The CAS CARAQA is a comprehensive continuing education programme, specifically tailored to the needs of medical technology and in-vitro diagnostics professionals. It is aimed at anyone involved in the life cycle of a medical device, from supplier to manufacturer to distributor:

• Employees at manufacturers and suppliers of in-vitro diagnostics and medical devices who work in regulatory affairs, quality management or clinical affairs
• Staff who support in-vitro diagnostics or medical devices during market approval.
• Employees in medical device or in-vitro diagnostics development
• Manufacturing and production staff
• Doctors, scientists or inventors of medical devices
• Staff involved in clinical studies or quality/regulatory processes in healthcare facilities

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 40. It takes place at the FHNW School of Life Sciences, Campus Muttenz. Lessons are every Tuesday, with a break during Christmas and New Year, and lasts until week 14.

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.

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