LS00EN31 Fundamentals of Medical Device Approval Process and Quality Control (2 cr)
Cooperation network course
Network: FysNet - Physics Education Network
Available for: Doctoral studies, Master's students, Bachelor's students and Bachelor's and Master's students
This course is offered through the Network for FYSNET. These studies are available for bachelor's, master's and doctoral degree students studying in the Faculty of Mathematics and Science and the Faculty of Information Technology.
Description
Clinical evaluations and investigations on medical devices, markets and product development from a company perspective. Handling of deviations, incidents, and adverse events (vigilance system) concerning medical devices. Essential rules and regulations related to the medical devices within the EU market area.
Learning outcomes
Learning outcomes:
- Knows the essential European rules and regulations of medical devices concerning their development and regulatory approval process
- Recognizes the key characteristics of the approval processes
- Knows the public entities essential to the processes and knows where and how to find up-to-date information on regulatory matters related to medical devices in Europe
The course develops the following generic skills: internationality, critical thinking, identification and development of expertise.
Additional information
The course is arranged three times per year starting at September, January-February, and May.
Offering data:
The course is open to everyone.
Further information:
The course is scheduled and arranged three times during the academic year.