CARAQA - Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics
Fachhochschule Nordwestschweiz FHNW > Hochschule für Life Sciences
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Description de la formation
CAS: Certificate of Advanced Studies (CAS) ist eine Nachdiplomausbildung der Hochschulen und entspricht mindestens 10 ECTS.
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
Plan de la formation
1 ECTS-Kreditpunkt entspricht einem Arbeitsaufwand von 25 bis 30 Arbeitsstunden.
- Introduction to the world of devices
- Course 1: Regulatory affairs, design and submissions
- Course 2: Quality Management
- Course 3: Clinical Affairs
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.
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
- Certificate of Advanced Studies CAS
CAS FHNW in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics
Lieu / adresse
- Muttenz (BL)
Début des cours
Durée de la formation
26 days over 6 months
- À temps partiel
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.
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