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Introduction to quality and regulation for medical product development

Individual course

Course content:

  • Most common phases of R&D project, from research to the product launch
  • Quality systems for medical device development
  • Medical devices: definitions, packaging, sterilisation, registrations and regulatory
  • Testing (mechanical, biomechanical, clinical, and statistical), standards and safety (electrical, biological)

After completing the course, the student:

  • 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.

Responsible teacher

Tampere University
Timo Allinniemi
timo.allinniemi(at)tuni.fi

Contact person for applications

FITech
Pilvi Lempiäinen , Service designer
pilvi.lempiainen(at)fitech.io
Start the application process
Start the application process
Category:
Technical studies
Topic:
Biomedical engineering
Course code:
BMT-62237
Credits:
5 ECTS
Level:
Teaching period:
2.3.–31.5.2020
Application deadline:
24.2.2020
Host university:
Tampere University
Study is open for:
Adult learner,
Degree student
Teaching methods:
Blended
Place of contact learning:
Tampere
Language:
English
Study suitable for:
MSc or PhD students who want to get background for biomedical device or software commercialisation and regulation
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