Fundamentals of medical device approval process, acad. year 2023-2024
Open university
- Credits:
- 2 ECTS credits
- Location:
- -
- Continuous learning category:
- Environmental and natural sciences
- Teaching format:
- Online teaching
- Price:
- 30 € (VAT 0%)
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 device field within the EU.
After this course, the student:
- Knows the essential rules and regulations concerning the development and regulatory approval or medical devices,
- Recognizes the key characteristics of the approval processes, and
- 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.
Modes of study: The course is conducted as online studies three times each year. Passing the course requires that the student learns the provided materials, including online recordings, and completes the assignments / quizzes related to them according to the criteria announced with each assignment.
Teaching methods: Online studies.
The course is available online and it can be studied at three different time points during the academic year:
- between Sep 1st and Oct 31st in the fall of 2023,
- between Feb 1st and Mar 31st in the spring of 2024, and
- between May 8th and Jun 30th in the spring of 2024.
You can find these details, and these details in Finnish, from the study guide.
Please note that there is a different registration link below for each of the three time points.
Industry and research professionals, regulators and students.
For the academic year 2023-2024, our courses cost 15 e/ECTS credit.
For more information on study fees and payment and cancellation terms, please see: Registration, study fees and right to study | University of Eastern Finland (uef.fi). Study right will cover the lessons and exams.
Fees for purchasing/lending literature are not covered by the University.
If you can’t identify yourself using the Suomi.fi service, please contact our training secretary; their contact information is below.
Irrespective of time
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