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Opintojakso, lukuvuosi 2021–2022
BBT.MJS.143
Regulatory Requirements for Design and Manufacture of Medical Devices, 5 op
Tampereen yliopisto
- Kuvaus
- Suoritustavat
Opetusperiodit
Aktiivinen periodissa 4 (7.3.2022–15.5.2022)
Koodi
BBT.MJS.143Opetuskieli
EnglishLukuvuodet
2021–2022, 2022–2023, 2023–2024Opintojakson taso
Advanced studiesArvosteluasteikko
General scale, 0-5Vastuuhenkilö
Responsible teacher:
Minna VeirantoResponsible organisation
Faculty of Medicine and Health Technology 100 %
Coordinating organisation
MET Studies 100 %
Yhteiset osaamistavoitteet
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
Osaamistavoitteet
Lisätiedot
Vastaavat opintojaksot
Kokonaisuudet, joihin opintojakso kuuluu
Suoritustapa 1
Active participation in the lectures, accepted project work and final exam.
Kaikkien osuuksien suorittaminen on pakollista.
Participation in teaching
10.03.2022 – 06.05.2022
Aktiivinen periodissa 4 (7.3.2022–15.5.2022)
Exam
02.05.2022 – 15.05.2022
Aktiivinen periodissa 4 (7.3.2022–15.5.2022)