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CM100V Medical Technology Development under the Medical Device Regulation 4.0 credits

Administer About course

The aim of the course is that those who plan to work in healthcare or/and research with possible medical applications should have sufficient knowledge of current regulations in medical technology. Today, early testing for clinical data is increasingly important due to stricter regulatory requirements. This points to a need to know methods used to ensure regulatory requirements for new and existing medical devices and to be able to conduct pilot studies that are of such high quality that data can be used in future clinical studies.

Information per course offering

Course offerings are missing for current or upcoming semesters.

Course syllabus as PDF

Please note: all information from the Course syllabus is available on this page in an accessible format.

Course syllabus CM100V (Autumn 2022–)
Headings with content from the Course syllabus CM100V (Autumn 2022–) are denoted with an asterisk ( )

Content and learning outcomes

Course contents

The course includes a review of the following contents:

  • applicable directives, laws and regulations, including MDR
  • liability issues
  • applicable standards
  • requirements for CE marking of medical devices
  • requirements for clinical trials of medical devices
  • the concept of quality
  • requirements for a quality system
  • risk management
  • product and after-market monitoring

Intended learning outcomes

After completion, the participant will be able to:

  • Apply the current medical technology regulations to medical technical product development
  • Identify critical risks in the development of medical technology products
  • sketch clinical trials including medical devices
  • Identify needs for quality management systems applied to the development of medical technical products

Literature and preparations

Specific prerequisites

Bachelor’s degree in engineering or biomedical science. English B

Literature

You can find information about course literature either in the course memo for the course offering or in the course room in Canvas.

Examination and completion

Grading scale

P, F

Examination

  • TEN1 - Written exam, 4.0 credits, grading scale: P, F

Based on recommendation from KTH’s coordinator for disabilities, the examiner will decide how to adapt an examination for students with documented disability.

The examiner may apply another examination format when re-examining individual students.

If the course is discontinued, students may request to be examined during the following two academic years.

Examiner

Profile picture Dmitry Grishenkov

Ethical approach

  • All members of a group are responsible for the group's work.
  • In any assessment, every student shall honestly disclose any help received and sources used.
  • In an oral assessment, every student shall be able to present and answer questions about the entire assignment and solution.

Further information

Course room in Canvas

Registered students find further information about the implementation of the course in the course room in Canvas. A link to the course room can be found under the tab Studies in the Personal menu at the start of the course.

Offered by

CBH/Biomedical Engineering and Health Systems

Main field of study

Medical Engineering

Education cycle

First cycle