Certificate of advanced studies in clinical, regulatory and quality affairs for medical devices and in-vitro diagnostics

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

• ECTS points: 13
• Next start: Jan 09, 2024
• Final application date: Nov 10, 2023
• Teaching language: English
• Place: FHNW Campus Muttenz
• Cost: CHF 8’800 (including examination fees)
• Duration: 26 weeks

CARAQA training is tailored to equip participants with the essential skills required by the MedTech industry. With the evolving dynamics of CA/RA/QA roles, our aim is to cultivate a diverse set of technical and interpersonal skills. This prepares participants to progress to decision-making positions within their organisations and play a pivotal role in maintaining the company's competitive edge and long-term viability. During the CARAQA training, participants will have the opportunity to fulfil professional development requirements that are com-pliant with both EU and US regulations. Therefore, they will gain knowledge to facilitate a seamless transition to the new requirements under MDR/IVDR and US FDA.

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 Au-thorities 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