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Regulatory requirements for design and manufacture of medical devices

Individual course

After completing this course, the student:

  • is able to describe the regulatory pathway of a medical device from description of the intended purpose to placing into market and putting into service
  • is able to recognise the general safety and performance requirements for a medical device including the principles of risk management and clinical evaluation
  • can explain the main elements of a quality system covering design and manufacture and choose a conformity assessment procedure based on classification rules
  • is able to understand the main principles and challenges of vigilance system and post-market surveillance

Course requirements:

You can either attend the lectures in Tampere University’s campus or watch them online. If student misses a lecture, they will be given an extra assignment. Course exercises are the same for all students, regardless of how they complete the course.

More information in Tampere University’s study guide.

Further information about the studies

Tampere University
Minna Kellomäki , Professor
minna.kellomaki(at)tuni.fi

Responsible teacher

Tampere University
Jari Hyttinen
jari.hyttinen(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-62107
Credits:
5 ECTS
Teaching period:
2.3.–31.5.2020
Application deadline:
9.2.2020
Host university:
Tampere University
Study is open for:
Adult learner,
Degree student
Level of studies:
Advanced
Teaching methods:
Online
Language:
English
Study suitable for:
MSc or PhD students who want to get background for biomedical device or software commercialisation and regulation