CAS CARAQA ‘23 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 School of Life Sciences FHNW offers a unique training opportunity for Medtech professionals facing the current major regulatory challenges. The CAS-Program fulfils the requirements of article 15 of MDR / IVDR.
Supported by
The Swiss Medtech and In-Vitro Diagnostic industries are facing a dynamic and highly challenging situation. On May 26th 2021 the Medical Device Regulation (MDR) became the only regulation applied to medical device manufacturers throughout Europe; major changes and new requirements were introduced. For the diagnostics world, this change is on the horizon as well; from May 26th 2022 the In-Vitro Diagnostic Medical Device Regulation (IVDR) will fully apply. Additionally, the Swiss Federal Government has decided to terminate negotiations on the EU-Swiss Institutional Framework Agreement. As a direct consequence, the Mutual Recognition Agreement is not being updated, forcing Swiss companies to act as if from a third country and establish European Representatives in order to access the European market.
CAS CARAQA: Clinical, Regulatory and Quality Affairs for Medical Devices & In-Vitro Diagnostics To support and strengthen the economic power of this sector, access to this most important market has to be assured, and Swiss manufacturers must be well prepared for the new requirements in the MDR and IVDR regulatory landscape. To train and empower professionals involved in quality, regulatory or clinical affairs to handle these challenges, the FHNW School of Life Sciences and Medidee®, supported by Swiss Medtech, offer the CAS CARAQA program – the Certificate of Advanced Studies in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics (CAS CARAQA). 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 the responsibility within their company for regulatory compliance (PRRC) according to Art. 15 MDR and IVDR. Already more than 100 participants have successfully followed CARAQA in Muttenz, Yverdon-Les-Bains, Louvain-La-Neuve in Belgium.
Testimonial
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 programwas 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.
Content
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:
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 to deal 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 structuring
Technical expertise in key subjects such as risk management, biocompatibility, usability, and software validation, according to current standards
Introduction to the world of devices
Understanding the MedTech environment
Getting to grips with product life cycle
Positioning and interacting with the entities involved
Course 1: Regulatory affairs, design and submissions
Structuring and implementing risk management
Integrating regulatory requirements during design
Managing implementation of directives, standards and recommendations
Maintaining regulatory conformity during product life cycle
Preparing the company for audits
Course 2: Quality Management
Structuring the Quality Management System deployment
Organizing documentation and its evolution
Supervising process control
Managing critical quality processes such as audit, improvement, changes
Course 3: Clinical Affairs
Structuring and organizing clinical / performance evaluations
Organizing a clinical investigation
Performing a literature review
Managing post-marketing studies
Overview
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.
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 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 Program.
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 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
The program will take place at the School of Life Sciences FHNW, Campus Muttenz.
Every Tuesday (except Easter), 26 weeks
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.
