CAS CARAQA

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.

Training objectives

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

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.