Structure + Content
Objectives + Skills
- 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.