CARAQA - Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics
Program overview
- Type of courseUniversities of Applied Sciences, Berufsorientierte Weiterbildung
- DegreeCertificate of Advanced Studies CAS Certificate of Advanced Studies FHNW Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics
- Course languageEnglisch
- Course formatIn-person instruction
- Time commitmentPart-time
- Duration
26 days over 6 months
What the program looks like
European medical device and in-vitro diagnostics regulations have increased complexity for the sector, posing major challenges for clinical, regulatory and quality affairs. Get to know these disciplines, how combine them efficiently, exchange ideas with experts to ensure long-term compliance with product regulations and become a key resource in your company.
- Essential knowledge of clinical affairs, regulatory compliance and quality assurance.
- Connect clinical affairs, regulatory and quality assurance – vital for success in modern MedTech environments.
- Benefit from a highly interdisciplinary, practice-driven learning experience.
- Stay ahead with insights into the latest regulatory and clinical developments.
- Develop a broad range of technical and interpersonal skills that equip you to drive your company’s competitive edge and long-term success.
- Grow your network by connecting with leading MedTech experts and peers.
3 Modules:
- Regulatory Affairs
- Qualitiy Assurance
- Clinical Affairs
Admission
At least one of the following admission requirements must be met:
- Tertiary educational qualification (at least Bachelor’s degree level) and relevant professional experience.
- Federal Diploma of Higher Education (from a Swiss “Höhere Fachschule” or “eidg. HFP” or “eidg. BP”) and at least 3 years’ professional experience in a subject relevant to the programme.
- At least 5 years’ professional experience in a subject relevant to the programme and successful completion of continuing education courses (in-company or CAS/MAS/DAS), or partially completed tertiary education (> 50%).
Costs
CHF 8'800.-
Für weitere Informationen zu den Kosten siehe Website des Anbieters.
Remarks
The programme is offered with our partner Veranex and is part of the European CARAQA network. Veranex is the only comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. They offer expert guidance from concept through to commercialisation, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance.