Max amount of FITech students: 20
Persons without a valid study right at a Finnish university or university of applied sciences have preference to this course.
This course is intended to expose the student to the regulatory environment within a European context. This will enable them to be more aware of what is required, and how to be prepared for the necessary health technology assessments such that the product they are designing can move through the regulatory processes at an accelerated rate.
Course contents
- Principles and methodologies of health technology assessment
- Basics of regulatory frameworks
- Regulatory impact assessments for health technologies
- Evaluation and analysis of the adoption and diffusion of health technologies
Learning outcomes
After the course, the students
- demonstrate understanding of health technology assessment principles
- navigate regulatory frameworks and compliance
- conduct regulatory impact assessments for health technologies
- evaluate adoption and diffusion of health technologies
Course material
The course centres around Regulation (EU) 2017/745 on medical devices. Beyond this, additional resources will be recommended and provided by the responsible teacher. Some of the lecture content will be available through online videos.
Teaching schedule
- Video lectures will be available online.
- In-person discussion sessions on Fridays 12:15-16:00. If you cannot participate to the sessions you will need to complete case studies/reflections on the weekly topic.
Completion methods
You can complete the course fully online or by attending in-person sessions.
- The primary completion method is based on project work, evaluated through interim presentations and a final report. This will either be in groups, or individually depending on whether the student is attending in-person or remotely.
- If the student is attending in-person, participation in the discussion sessions will form a part of the assessment.
- If the student is attending remotely, completion of the weekly case studies/reflections will form a part of the assessment.
More information in the Aalto University study guide.
You can get a digital badge after completing this course.