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Course unit, curriculum year 2024–2025
BBT.MJS.143
Regulatory Requirements for Design and Manufacture of Medical Devices, 5 cr
Tampere University
- Description
- Completion options
Teaching periods
Active in period 4 (3.3.2025–31.5.2025)
Course code
BBT.MJS.143Language of instruction
EnglishAcademic years
2024–2025, 2025–2026, 2026–2027Level of study
Advanced studiesGrading scale
General scale, 0-5Persons responsible
Responsible teacher:
Minna VeirantoResponsible organisation
Faculty of Medicine and Health Technology 100 %
Coordinating organisation
MET Studies 100 %
Common learning outcomes
International outlook and global responsibility
Sustainable development goals
Goal 3: Good Health and Well-Being
Core content
- Regulatory pathway of a medical device as an integral part of an innovation path way
- Regulatory framework for medical devices, including in vitro diagnostic medical devices in the European Union
- Basic definitions and key concepts of the Regulations on medical devices and the requirements for economic operators
- General safety and performance requirements for medical devices
- Quality management system for medical devices
- Conformity assessment
- Vigilance system
- Post-market surveillance
Complementary knowledge
- Intellectual property rights considerations during medical device product life cycle
- Understanding the use of harmonised standards and the requirements for a risk management system and clinical evaluation
- Understanding of technical documentation and the requirements for a quality management system (with a reference to the standard EN ISO 13485:2016)
- Deeper understanding the relation of the classification rules to the conformity assessment procedures and the role of conformity assessment bodies
- Understanding the requirements for registration, traceability and vigilance system, and the role of Competent Authorities in market surveillance
Special knowledge
- Supplementary information of selected elements of regulatory requirements
Learning outcomes
Further information
Equivalences
Studies that include this course
Completion option 1
The course consists of lectures, assignments and final exam.
Completion of all options is required.
Participation in teaching
03.03.2025 – 27.04.2025
Active in period 4 (3.3.2025–31.5.2025)
Exam
29.04.2025 – 10.05.2025
Active in period 4 (3.3.2025–31.5.2025)