Certificate of Advanced Studies (CAS) FHNW in Clinical, Regulatory and Quality Affairs (CARAQA) for Medical Devices and In Vitro Diagnostics

• ECTS points: 15
• Next start: 21.09.2027
• Final application date: 13.07.2027
• Teaching language: English
• Place: FHNW Campus Muttenz
• Cost: CHF 8 600 (Early Bird, at least three months before the programm starts), Regular Fee CHF 9 100 (including examination fees)
• Duration: 26 days

The CAS CARAQA program enables you to develop expertise in regulations, clinical affairs and quality assurance while facilitating efficient networking. This is essential for achieving regulatory compliance efficiently and effectively. You are trained to build appropriate communication and cooperation within your organization and with third parties. The knowledge and skills acquired on the course are essential for ensuring regulatory compliance and product quality, and therefore for fulfilling the role of a Person Responsible for Regulatory Compliance in accordance with Art. 15 of the regulations.
Upon completing this program, you will be able to:

• Demonstrate an in-depth understanding of the European Medical Device Regulation (EU 2017/745) and the In Vitro Diagnostic Medical Device Regulation (EU 2017/746)
• Support product development with targeted regulatory and quality expertise, and assure regulatory compliance
• Strategically plan and manage necessary action items such as clinical evaluations, ISO 14155 compliant investigations, and IVD performance studies
• Communicate effectively with Notified Bodies and National Competent Authorities – even in challenging situations
• Lead implementation of ISO 13485 compliant quality management systems
• Align supply chain, production and marketing processes with regulatory requirements
• Apply expert knowledge such as risk management, biocompatibility, usability and software validation in accordance with current standards

You will complete the continuing education program by writing a thesis on a topic of your choice. This will enable you to apply your knowledge directly to your professional setting.