Course unit, curriculum year 2023–2024
BBT.MJS.142
Introduction to Quality and Regulation for Medical Product Development, 5 cr
Tampere University
- Description
- Completion options
Teaching periods
Active in period 1 (1.8.2023–22.10.2023)
Active in period 4 (4.3.2024–31.5.2024)
Course code
BBT.MJS.142Language of instruction
EnglishAcademic years
2021–2022, 2022–2023, 2023–2024Level of study
Advanced studiesGrading scale
General scale, 0-5Persons responsible
Responsible teacher:
Minna VeirantoResponsible teacher:
Mari Pekkanen-MattilaResponsible organisation
Faculty of Medicine and Health Technology 100 %
Coordinating organisation
MET Studies 100 %
Common learning outcomes
International outlook and global responsibility
Core content
- Most common phases of R&D project. From research to the product launch.
- Quality Systems for medical device development. Why it's needed? And how we can use it to improve the product safety?
- Medical Devices. Definitions, packaging, sterilization, registrations and regulatory.
- Testing (mechanical, biomechanical, clinical, and statistical), standards and safety (electrical, biological).
Complementary knowledge
- Understanding the connections between different phases of the project, and to have overall knowledge about the whole process.
- Deeper understanding of QS
(including SOP, CAPA, Auditing, DMR, traceability, risk assessment) - Understanding the main equalities and differences of regulatory demands between the different countries.
- To understand the main methods and why/where we need these results?
Learning outcomes
Further information
Equivalences
Studies that include this course
Completion option 1
The course consists of various mandatory tasks, discussions and lectures. Implementation in the first period is primarily intended for international degree students and exchange students, also for other finnish degree programmes than Biotechnology and Biomedical Engineering. Implementation in the 4th period is primarily intended for the degree students in Biotechnology and Biomedical Engineering.
Participation in teaching
29.08.2023 – 20.10.2023
Active in period 1 (1.8.2023–22.10.2023)
05.03.2024 – 05.05.2024
Active in period 4 (4.3.2024–31.5.2024)