CAS CARAQA

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:

• 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
• Managing software compliance
• Accompanying product design and industrialization
  
• Structuring regulatory submissions documentation
  
• Managing market events: incidents, reporting, recalls
• 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

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.

The program will take place at the School of Life Sciences FHNW, Campus Muttenz.

• Every Tuesday (except Easter)
  
• Final exam:
• July 19^th 2022
• Submission of final thesis: August 2^nd 2022
• Defense: September 6/7th 2022
  

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.