Caraqa

CAS CARAQA ’24 will start in January next year. Detailed information can be obtained at our information events. More information please find in the info box above.

In collaboration with Medidee®, the FHNW School of Life Sciences offers a unique training opportunity for Medtech professionals facing the current major changes in regulations. This program delivers detailed insights into regulatory, clinical affairs and quality management for Medical Devices and In Vitro Diagnostics, combined with hands-on experience from experts on how to adopt and apply this knowledge in your professional context.

The European Medical Device and In-Vitro Diagnostic Medical Device industry is facing serious challenges due to recent significant changes in regulations. Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR) have become the sole European regulations, increasing the burden on stakeholders in the Medical Device sector. Con-verting to MDR or IVDR is currently firms’ greatest challenge, along with increased documentation requirements, higher barriers and longer market approval times. Swiss companies are facing even more challenges, as the EU/CH Mutual Recognition Agreement has not been up-dated, forcing Swiss companies to act as a third country and establish European Representatives for the EU market, while applying the "Swiss Finish" of the MDR and IVDR for the domestic market.

The CAS CARAQA is designed to support and strengthen the economic power of this sector by training and empowering professionals involved in quality, regulatory or clinical affairs to handle these challenges. The FHNW School of Life Sciences and Medidee® offer the CAS CARAQA program - the Certificate of Advanced Studies in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics. This continuing education program offers participants advanced knowledge, hands-on experience and applied skills at first-hand from experts in the medical and in-vitro diagnostic medical device industry. The program is designed to enable participants to take on responsibility within their organisation for regulatory compliance (PRRC) according to Art. 15 MDR and IVDR.

CAS CARAQA in Muttenz is part of the European CARAQA network. So far more than 100 participants have successfully completed CARAQA in Muttenz, Yverdon-Les-Bains and Lou-vain-La-Neuve in Belgium.

I enjoyed being back at the University of Applied Sciences and Arts Northwestern Switzerland FHNW. The main topis clinical affairs, regulatory affairs and quality affairs for medical devices & in-vitro diagnostics were presented in an interesting, exciting and multifaceted way. It was great to have so many different lecturers, who all have had well 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 was optimal with around 15 people. It was great that we were so many different people with such different backgrounds. This also made it possible to learn from each other in the exercises and in the discussions and to get an insight into how different problems are solved in other companies. For these reasons, I can recommend the CAS CARAQA programme with good conscience to anyone who is also active in this field.

Dennis Wald is Head of Qualification and Validation at Chemgineering Switzerland AG. Thanks to his CARAQA CAS degree, Dennis can provide invaluable support to the business in the medical technology sector and expand his field of responsibility in the firm.
Dennis Wald completed his BSc in pharmaceutical technology at the FHNW School of Life Sciences. "I was interested in medical technology from an early age, but the medical technology specialisation focused too much on image processing and software for me at the time" says Dennis. He never fully left the field of medical technology however. "My wife is a doctor, and thanks to her I have always been somewhat involved with medical technology and its applications" he says. And throughout his career there has been contact with medical devices, especially in the area of combination products.

In January 2022, professional and personal circumstances meant that Dennis could take the opportunity to enrol in the CARAQA CAS program. "My main motivation was personal interest; I’m delighted that my employer supported me in my professional development and that I can now apply in my job what I learned on the course". In future, he will provide essential support for challenging customer projects with focus on medical technology and optimize internal quality management processes for medical technology.
Since the European Medical Device Regulation (MDR) came into force, and negotiations on bilateral treaties between Switzerland and the EU suspended, Swiss medtech companies have faced additional challenges. "It was fascinating to get first-hand insights into the uncertainty in the medtech sector" says Dennis. It became clear to him 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 assurance is ensured during medical technology product development. In recent years, I have had little to do with product development in pharmaceutical industry projects. There, the focus was mainly on production and thus on manufacturing processes and equipment" he explains.
For Dennis Wald, the CARAQA CAS program 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 discussion with my supervisor also greatly enriched the course" Dennis concludes.

Alba Gutiérrez is a biomedical engineer specialized in Medical Imaging and 3D Modelling. During her master’s studies at the FHNW School of Life Sciences, she became aware of how important Regulatory Affairs are for medical device manufacturers and how they drive innovation. Fascinated by this insight, it became clear to her that she wanted to specialize in this field and she found out about the CAS program in Clinical Affairs, Regulatory and Quality for Medical Devices and In-Vitro Diagnostics (CARAQA) offered by the School of Life Sciences. She enrolled in and completed the CAS program in parallel with her MSc studies. "Attending the CAS CARAQA program   was a huge opportunity for me! Ultimately it enabled me to specialize in my area of interest and drive my professional career in the direction I wanted to go" says Alba.

Alba states that the program enabled her to become aware of the complexity involved as she learned about the different areas of the field: clinical, regulatory and quality affairs. Furthermore, she gained insights into the workings and processes behind the regulations.  "I remember the many lively and fruitful discussions I had with my inspiring classmates and lecturers on these topics. I really appreciate the people I had the chance to meet in this program and I am still in contact with many of them" Alba adds.
After having successfully completed the CAS CARAQA Program, many professional opportunities opened up for Alba. In her current position she is working as a project associate at Medidee, a global services provider in Medical Devices and In-Vitro Diagnostics. "Our services cover all steps of product development, from initial project idea to certification and regulatory clearance. I am so grateful to have found my dream job, also thanks to the CAS CARAQA" says Alba.

The adoption of new European regulations on medical devices and in-vitro diagnostics has triggered major changes in the Medtech sector, resulting in pressure on employees in Clinical Affairs, Regulatory Affairs and Quality Assurance - CA/RA/QA.

Countries in the Gulf, Asia and South America now have requirements that are as complex as those in Europe or the USA. Exporting to these countries is therefore a challenge for Swiss firms.

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.

The CAS CARAQA develops the following skills:

The program is aimed at people in medical device and in-vitro medical device companies (as well as subcontractors) who are facing direct or indirect challenges in a CA/RA/QA environment.

As the instruction and educational materials are in English, proficiency in English (reading and writing) is a prerequisite.

Specific Admissions if the applicant does not qualify as per formal criteria above:

All three courses are subject to 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 as per the guidelines laid down in the program. The device can be individually selected by each participant and may be linked to his/her professional activity. 

A personal coach will be assigned to each participant, responsibility for supporting and supervising the CAS thesis. The thesis is written in English.

Final Exams: 18 July 2023
Thesis Submission: 2 August 2023
Defense: 5/6 September 2023

Medidee is a consulting firm specialised in Regulatory, Clinical affairs and Quality for medical devices and IVD. Medidee supports manufacturers, public organisations and health professionals facing the complex topics of compliance with legal requirements associated with the development, manufacture, validation and commercialisation of a wide range of technologies in the MedTech and BioTech fields.

Products include medical devices, active implants, IVD, standalone & embedded software and standardised transplants. Support often starts as early as the ideation and innovation phase, hence the company keeps in close contact with academic and start-up ecosystems and interaction with suppliers during the industrialisation phase is often key. At later stages, Medidee acts as CRO to strategise, design and obtain the approval of clinical investigations and to support the execution. Another important area of activity is the development and ISO 13485 certification / 21 CFR 820 compliance of quality management systems to ensure that the product is developed and manufactured correctly. Medidee has offices in Switzerland, Germany, Belgium, Denmark and the USA.