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Introduction to quality and regulation for medical product development

Yksittäinen kurssi

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 Tampere University’s study guide.

Vastuuopettaja

Tampereen yliopisto
Eija Pirhonen
eija.pirhonen(at)tuni.fi

Hakua koskevat kysymykset

FITech
Monica Sandberg , Opintoasioiden suunnittelija
monica.sandberg(at)fitech.io
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Kategoria:
Tekniikan opinnot
Teema:
Biolääketieteellinen tekniikka
Kurssikoodi:
BMT-62237
Opintopisteet:
5 ECTS
Hinta:
0 €
Taso:
Opetusaika:
8.3.–31.5.2021
Viimeinen hakupäivä:
1.3.2021
Järjestävä yliopisto:
Tampereen yliopisto
Kohderyhmä:
Tutkinto-opiskelija
Opetustavat:
Monimuoto-opinnot
Opetuspaikkakunta:
Tampere
Kieli:
Englanti
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