CARAQA

The certified curriculum for preparing Regulatory, Clinical and Quality experts in the MedTech world.

The certified curriculum is designed to prepare regulatory, clinical, and quality experts in the MedTech field. This program is tailored for professionals in the European medical device and in vitro diagnostics sectors. Our educational program offers participants advanced knowledge, practical experience, and skills directly from industry experts.

Certified training program

Delivered by state accredited engineering schools

Multiple locations

Classess available in Switzerland and Belgium

200+ alumni

7 years of delivery over 4 universities and 3 countries

PROGRAMS

Our Current Programs

HEIG-VD
Yverdon-les-Bains, Switzerland

Every Friday – September to April classes on site

Currently ongoing – Next session planned for September 2025

FHNW logo

 “School of Life Sciences FHNW
Basel Muttenz, Switzerland

Every Tuesday – September TO APRIL, classes on site

Next class starts: September 30th 2025. 

UCLouvain
Louvain-la-Neuve, Belgium

Every Friday + online every other Saturday – January to September

Next class starts: January 10th 2025. Registrations are open!

Learn about the program

Next Upcoming Info Events

Meet us onsite or online during one of our organized information events in order to get an in deapth presentation of the University and the program.

HEIG-VD
Yverdon-les-Bains, Switzerland

No infoevents planned. Contact us to register to the mailing list for the program

School of Life Sciences FHNW
Basel Muttenz, Switzerland

No infoevents planned. Contact us to register to the mailing list for the program

UCLouvain
Louvain-la-Neuve, Belgium

November 28th, 2024, 17:00-18:00 (UTC+1)
Online info event

WHY

Why CARAQA?

Join a growing market

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).

Meet the PRRC requirements

Article 15 of the MDR/IVDR requires that manufacturer and authorized representative identify a person responsible for regulatory compliance (PRRC). The CARAQA training program is delivered by state accredited engineering schools fulfiling Article 15 requirements.

Fullscope overview

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.

Diversity of teaching

Designed to integrate a good balance of theory and hands-on practice, the CARAQA program provides a high-level preparation to match the competences required by the MedTech Industry.

Overview of World regulations

The CARAQA training will provide you with an overview of regulatory and quality requirements in the world, including requirements in US, Canada, China, AESAN, Australia, UK and Switzerland.

Living community

Once part of the CARAQA network every student will become part of the CARAQA community. The community benefits of two free masterclasses per year, interesting job postings and more…

CHOOSE US

The program

Faced with the evolution of CA/RA/QA functions, the aim is to develop a broad range of technical and human skills in order to evolve towards the organisation’s decision-making centres and play a key role in maintaining the company’s competitiveness and sustainability.
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Regulatory

Optimal preparation for MDR 2017/745, IVDR 2017/746 and US 21CFR parts 800-1299 regulatory frameworks
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Quality

Leadership in the deployment and maintenance of Quality Management Systems under ISO 13485 and US QSR
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Clinical

Strategic planning and management of clinical evaluations, investigations under ISO 14155 and IVD performance studies
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World Class Educators and case-studies

Variety of industry experts to reflect both start-up and corporate realities

Interested in the CARAQA program? Drop your email below, and we’ll send you the brochure for the upcoming edition!

Request the brochure

Program coordination by Veranex Switzerland SA

TESTIMONIALS

What Our Students Say

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, CARAQA Alumnus 2022
The whole course has been extremely well structured, interesting and well taught.
Every speaker was inspiring, full of knowledge and experience. I enjoyed the trainers’ personal comments about their experiences in the industry in relation with the training’s content. The presentations included good pratical case studies.
It was for me an optimal preparation to face the new challenges of the upcoming IVDR.
I highly recommend this training to anyone having to navigate and comply with the medical devices regulations and approval processes.

Tiphaine Descombes

RA/QA Manager, CARAQA Alumna 2020
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, CARAQA Alumnus 2022
After more than 20 years in QA /RA in chemical industry, I have attended the CARAQA programm in 2021 /2022. Thanks to this program given by professionals of Medical Device Industry, I have acquired the knowledge needed to join a very dynamic company creating innovative therapies. The CARAQA programm has been a key enabler of my career transition.

Nathalène Hippolite

Quality Assurance & EHS manager, CARAQA Alumna 2022
CARAQA TEAM

Meet the CARAQA managing team

Didier Maillefer

Prof Didier Maillefer

School of Management and Engineering, HEIG-VD

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David Hradetzky

Prof David Hradetzky

School of Life Sciences FHNW

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Renaud Ronsse

Prof Renaud Ronsse

Ecole Polytechnique de Louvain, UCLouvain

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Elena Lucano

Dr Elena Lucano

Training Lead, Veranex Switzerland SA

 

Zuzana Robin

Training Manager, Veranex Switzerland SA

 

FAQ

Frequently Asked

What is the typical CARAQA student profile?

The program is aimed at people altready in medical device and in vitro medical device companies and suppliers who are directly or indirectly facing challenges in a CA/RA/QA environment. People wishing to develop their skills in this direction or that are aiming for a career change in the field are also very welcome.

Are there any admission criteria?

Formal entry qualifications are:

  • Tertiary Educational Qualification (at least Bachelor’s level) and relevant work experience
  • or Diploma HF (from a Swiss “Höhere Fachschule”) and relevant work experience

An alternative to these qualifications, the applican should have some work experience corresponding to or related to the relevant Continuing Education Program.

In what language are CARAQA classes taught?
All the instruction and educational materials are in English, proficiency in English (reading and writing) is a prerequisite.
How is the training structured?

The program runs annually, with the starting date depending on the location. Lessons are held weekly for approximately 25 weeks, typically on a full workday (9:00 a.m. to 17:00 p.m.), though this schedule may vary by location. Sessions are primarily delivered on-site at the university, with some lectures provided online (the number of online lectures varies by location). The program concludes with a final written exam, followed by the writing and presentation of an individual thesis. The thesis involves a comprehensive CA/RA/QA study of a medical device or in vitro diagnostic (IVD) device, following guidelines set out in the program. Participants can select their own device, ideally one that relates to their professional activities. The thesis is written and defended in English before a committee.

How much does the program costs?
The cost of the CARAQA program is defined by each university. Please consult the university website using the links above for specific information.
How many ECTS points is the program?

Depending on the location the ECTS points go from 12 to 17.

Is there any training material to be purchased for the program?

All necessary materials will be provided by the university as part of the program. No additional standards or textbooks need to be purchased beyond the provided resources. Some universities also offer free access to scientific papers and standards through the university network, accessible upon student registration.

Book A Call Today!

Book a 15′ call today with our administration in order to have all your questions answered and see how best CARAQA can fit your needs or your schedule.
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