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Course unit, curriculum year 2020–2021
BMT-62107
Regulatory Requirements for Design and Manufacture of Medical Devices, 5 cr
Tampere University
- Description
- Completion options
Teaching periods
Active in period 4 (8.3.2021–31.5.2021)
Active in period 5 (1.6.2021–31.7.2021)
Course code
BMT-62107Language of instruction
EnglishAcademic year
2020–2021Level of study
Advanced studiesGrading scale
General scale, 0-5Persons responsible
Responsible teacher:
Minna VeirantoResponsible organisation
Faculty of Medicine and Health Technology 100 %
Common learning outcomes
International outlook and global responsibility
Core content
- Regulatory framework for medical devices in the European Union
- General safety and performance requirements for medical devices
- Quality management system for medical devices
- Conformity assessment
- Post-market surveillance
Complementary knowledge
- Understanding the basic definitions and key concepts of the Regulations on medical devices and the requirements for economic operators
- 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)
- 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
Learning outcomes
Further information
Equivalences
Studies that include this course
Completion option 1
Active participation in the lectures, accepted project work and final exam.
Completion of all options is required.
Exam
08.03.2021 – 30.06.2021
Active in period 4 (8.3.2021–31.5.2021)
Active in period 5 (1.6.2021–31.7.2021)
Participation in teaching
11.03.2021 – 30.04.2021
Active in period 4 (8.3.2021–31.5.2021)