The MedTech sector in Europe is grappling with the challenges posed by the Medical Device Regulation (EU 2017/745, MDR) and the In-Vitro Diagnostic Device Regulation (EU 2017/746, IVDR). The transition to the regulations in 2021 for medical devices and in 2022 for in-vitro diagnostics is still underway, creating additional burdens for certifying novel and existing devices. Swiss companies in particular are facing more difficulties as the Mutual Recognition Agreement has not been updated. This forces those firms into third country status, creating the need to establish European Representatives for the EU market, while implementing the "Swiss Finish" of the MDR and IVDR for the domestic market.
To strengthen and maintain the economic impact of this sector through professional development and empowerment of its members, Veranex and the FHNW School of Life Sciences offer the Certificate of Advanced Studies in Clinical, Regulatory, and Quality affairs for Medical Devices and In-Vitro Diagnostics - CAS CARAQA.
This program is designed for regulatory, clinical and quality experts in the MedTech world. Our continuing education programme provides participants with advanced knowledge, hands-on experience and first-hand skills from experts in the industry. The course structure enables participants to assume responsibility for regulatory compliance (PRRC) in accordance with Art. 15 MDR and IVDR within their organisation. With the evolving landscape of CA, RA and QA functions, our aim is to develop a diverse range of technical and soft skills. This will enable professionals to make key organisational decisions and play a vital role in maintaining the competitiveness and longevity of the company. The program provides in-depth insights into regulatory, clinical and quality management aspects, emphasising 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 150 participants have successfully completed CARAQA in Muttenz, Yverdon-Les-Bains, Lubeck and Louvain-La-Neuve in Belgium.
Testimonials
I enjoyed being back at the FHNW School of Life Sciences. The main topics clinical affairs, regulatory affairs and quality affairs 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 program to anyone who is 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. He 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 course specialization focused too much on image processing and software for me at the time" says Dennis. He never fully left the field 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 combination products.
In January 2022, professional and personal circumstances meant that Dennis could take the opportunity to enroll in the CARAQA CAS programme. "My main motivation was personal interest; I’m delighted that my employer supported me in my professional development and that I can apply what I learned on the course in my job". In future, he will provide essential support for challenging customer projects with a focus on medical technology and optimize internal quality management processes for medical technology.
Since the European Medical Device Regulation (MDR) came into force and Swiss/ EU bilateral treaty negotiations were 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 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 discussions with my supervisor also greatly enriched the course”.
Alba Gutiérrez is a biomedical engineer specializing 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: on finding out about the CAS CARAQA programme offered by the School of Life Sciences she enrolled and completed the programme in parallel with her MSc studies. “Attending the CAS CARAQA 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.
The programme showed Alba the complexity involved as she learned about the different areas of the field. 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” she adds. After having successfully completed the CAS CARAQA, many professional opportunities opened up for Alba. She is currently 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, in part thanks to the CAS CARAQA”.
Find more testimonials on the European CARAQA network website at www.caraqa.com
Content
Implementing the new European Regulations for Medical Devices and In-Vitro Diagnostics has led to significant changes in the European MedTech industry, putting a strain on clinical affairs, regulatory affairs and quality assurance (CA/RA/QA) staff. In Switzerland, companies face additional challenges due to an outdated Mutual Recognition Agreement.
In addition, countries in the Gulf, Asia and South America have introduced requirements that are as complex as those in Europe or the USA. As a result, exporting to these regions is a major challenge for Swiss companies.
CARAQA training is tailored to equip participants with the essential skills required by the MedTech industry. With the evolving dynamics of CA/RA/QA roles, our aim is to cultivate a diverse set of technical and interpersonal skills. This prepares 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. During the CARAQA training, participants will have the opportunity to fulfil professional development requirements that are compliant with both EU and US regulations. They will gain the knowledge to facilitate a seamless transition to the new requirements under MDR/IVDR and US FDA.
The CAS CARAQA develops the following skills:
Optimal preparation for MDR 2017/745 and IVDR 2017/746 regulatory changes
Strategic planning and management of clinical evaluations, investigations under ISO 14155 and IVD performance studies
Strategic and tactical communication for interaction with Notified Bodies and National Competent Authorities, and for dealing with crisis situations
Management and engineering support during new product development projects
Leadership in the deployment and maintenance of Quality Management Systems under ISO 13485 and US QSR
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 CARAQA training is structured around three main pillars: Clinical Affairs, Regulatory Affairs and Quality Assurance - CA/RA/QA. 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 MedTech industry.
Introduction to the world of Medical Devices and In-Vitro Diagnostics
Understanding the MedTech environment
Getting to grips with product life cycle
Positioning and interacting with the entities involved
Course 1: Regulatory Affairs
Integrating regulatory requirements during product design and product life cycle
Managing implementation of directives, standards, recommendations, and software compliance
Structuring and implementing regulatory submissions documentation and risk management
European Regulations: Medical Device Regulation (EU 2017/745, MDR) and In-Vitro Diagnostic Device Regulation (2017/746, IVDR), including Swiss Finish
State of Art
Device Classification
General Safety and Performance Requirements
Technical documentation
Conformity Assessment Procedures
Foreign Regulations: US FDA, Canada, China, ASEAN, Australia and UK
Regulatory Compliance in Europe and US
Risk Management
Instructions for use and Labelling
Sterilization
Usability
Electrical Safety and Electromagnetic Compatibility
Biocompatibility
Controlled Environments
Device Vigilance and Post Market
Combinational and substance based products
Digital Health
Software as a Medical Device
Software Management
Cybersecurity
Course 2: Quality Management
Structuring the Quality Management System deployment
Organizing documentation and its evolution
Supervising process control and controlling suppliers
Managing critical quality processes such as audit, improvement, changes
Quality Management for Medical Devices (ISO 13485)
Architecture and deployment
Documentation requirements
Management requirements
Resource management
Product realization
Production and Process controls
Customer-related processes
Design and development
Purchasing and Suppliers
Process Validation
Measurement, analysis and improvement
US CFR21 820 and FDA audits
MDSAP
Course 3: Clinical Affairs
Structuring and organizing clinical / performance evaluations
Organizing a clinical investigation
Performing a literature review
Post Market Surveillance and Post Market Clinical Follow-up
Clinical Investigation:
Study Design
Investigational Strategies
Clinical Evaluation of Medical Devices and In-Vitro Diagnostics
General Data Protection Regulation (GDPR)
Overview
The program is aimed at people in medical device and in-vitro medical device companies, as well as subcon-tractors, who are facing direct or indirect challenges in a CA/RA/QA environment.
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
Laboratory assistants involved in the development of new analytical methods or process automation
Employees involved in clinical studies or quality/regulatory processes in a healthcare organization
Formal entry qualifications:
Tertiary Educational Qualification (at least Bachelor’s degree level) and relevant work experience
or Diploma HF (from a Swiss “Höhere Fachschule”) and relevant work experience
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:
At least 3 years’ work experience corresponding to or related to the relevant Continuing Education Programme.
CAS FHNW in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics
All three courses are subject to a final written exam and the writing & 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 to support and guide the participant during the CAS thesis. The thesis is written in English.
The final examinations take place two weeks after the end of the training days in week 29. The thesis is due in week 31 and is defended in week 36. All on-site sessions are scheduled for Tuesdays., although the defense may take place on other days (typically Wednesday).
The program runs annually starting in the second week of the year. It will take place at the FHNW School of Life Sciences, Campus Muttenz. Teaching is all day every Tuesday with a break during Easter and lasts until calendar week 27.
The program is delivered annually starting in the second week of the year. It will take place at the FHNW School of Life Sciences, Campus Muttenz. Training day is every Tuesday, whole day, with a break during the Easter season and will last until calendar week 27.
Figure 1: Yearly schedule for the CAS CARAQA. Training days, examinations and defense days are on Tuesdays.
Veranex is the only comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. We 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 accelerated market viability assessment. At every stage our clients achieve efficiencies in cost and time, while our comprehensive solutions unify the entire development process. 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.
