Takaisin kaikki kurssit

Introduction to quality and regulation for medical product development

Yksittäinen kurssi

If you are taking this course as part of a FITech minor, please note that all minors will be offered for the last time in the academic year 2021-2022. Please check the individual courses for updates regarding future availability.

Max amount of FITech students: 20

The course provides basic information on regulatory and quality requirements for medical products throughout the product’s life cycle. The course introduces the key concepts and definitions in the field and the stages of product development. Versatile product testing, product safety verification and related standards and requirements will be introduced.

Course 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).

After completing the course, you:

  • can explain the definitions introduced in the course and the main steps of a biomedical device product research and development process
  • can explain the main standards and regulations concerning medical devices in EU and USA and the main parts of the most common quality systems for the medical devices
  • can explain the most typical tests for electrical and biological safety as well as mechanical and biomechanical testing

More information in the Tampere University study guide.

Vastuuopettaja

Tampereen yliopisto
Eija Pirhonen

Hakua koskevat kysymykset

FITech-verkostoyliopisto
Fanny Qvickström, Opintoasioiden suunnittelija
Hakuaika on päättynyt
Hakuaika on päättynyt
Kategoria:
Tekniikan opinnot
Teema:
Biolääketieteellinen tekniikka
Kurssikoodi:
BBT.MJS.142
Opintopisteet
5 ECTS
Hinta:
0 €
Kurssin taso:
Opetusaika:
30.8.–24.10.2021
Viimeinen hakupäivä:
Hakuaika on päättynyt
Järjestävä yliopisto:
Tampereen yliopisto
Kuka voi hakea:
Tutkinto-opiskelija
Opetustapa:
Verkko-opetus
Opetuskieli:
Englanti
Oletko kiinnostunut tästä kurssista? Tilaa ilmoitus kurssin tietojen muutoksista suoraan sähköpostiisi! Voit peruuttaa tilauksen koska tahansa.