You are browsing the curriculum of an upcoming academic year (2024–2025).
Do you want to change to the ongoing academic year?
Course unit, curriculum year 2024–2025
BBT.MJS.145
Global Regulations and Standards for Biomedical Products, 5 cr
Tampere University
- Description
- Completion options
Teaching periods
Active in period 3 (1.1.2025–2.3.2025)
Active in period 4 (3.3.2025–31.5.2025)
Course code
BBT.MJS.145Language of instruction
englantiAcademic years
2024–2025, 2025–2026, 2026–2027Level of study
Syventävät opinnotGrading scale
Yleinen asteikko, 0-5Persons responsible
Vastuuopettaja:
Minna VeirantoVastuuopettaja:
Mari Pekkanen-MattilaVastuuorganisaatio
Lääketieteen ja terveysteknologian tiedekunta 100 %
Järjestävä organisaatio
MET yhteinen koulutus 100 %
Core content
Regulations and authorities in Asia, Africa, South America, Australia, and North America
Classification and regulatory pathways
Standards and practices
Biocompatibility and clinical testing
Labeling
Medical devices
In vitro diagnostic medical devices
ATMPs
Special programs
Harmonization
Global organizations
Learning outcomes
Compulsory prerequisites
Recommended prerequisites
Studies that include this course
Completion option 1
In addition to independent studying, the course has at least one joint start session at the beginning of the course. The instructions will be updated closer to the course.
Itsenäinen työskentely
07.01.2025 – 31.05.2025
Active in period 3 (1.1.2025–2.3.2025)
Active in period 4 (3.3.2025–31.5.2025)