CAS Regulatory Affairs in Life Sciences

• You are planning to work in the regulated environment in the medical device- or in the life sciences industry.
• You are currently working in the areas of development, manufacturing, quality management or regulatory affairs.
• You are responsible for the early detection and analysis of risks in the areas of medical technology, medical informatics or in the life sciences industry.

• You gain comprehensive knowledge of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) and demonstrate proficiency in their practical application.
• You acquire the necessary expertise to establish a quality management system (QMS) for medical devices, aligning with ISO 13485.
• You know the interfaces to processes such as risk management, usability engineering, reviews, design verification, design validation and process validations.
• You develop the capability to implement national regulations pertaining to reporting obligations and corrective measures in the event of serious incidents involving medical devices.
•  In a case study (semester work) you work on a real project or question from your company or from your own interest.

As a rule, a university degree and practical experience are required for admission. 
People with a high vocational training can apply, provided they have suitable professional experience and prior scientific and methodological knowledge. 

Requirements
Ideally, you possess a degree in medicine, pharmacy, or a related scientific field. Additionally, qualifications in medical technology, medical informatics, engineering, legal studies, material science, or business administration, or a related discipline, would be highly advantageous.

Language
The teaching language and the course materials are in English.

Costs
CHF 7500