Skip to main content
Till KTH:s startsida

CM100V Medical Technology Development under the Medical Device Regulation 4.0 credits

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

Termin

Information for Autumn 2024 Start 29 Jul 2024 single courses students

Course location

KTH Flemingsberg

Duration
29 Jul 2024 - 23 Aug 2024
Periods
Pace of study

67%

Application code

40025

Form of study

Normal Daytime

Language of instruction

Swedish

Course memo
Course memo is not published
Number of places

10 - 20

Target group
No information inserted
Planned modular schedule
[object Object]
Schedule
Schedule is not published
Part of programme
No information inserted

Contact

Examiner
No information inserted
Course coordinator
No information inserted
Teachers
No information inserted
Contact

Fernando Seoane Martinez (fsm@kth.se)

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 

Equipment

No information inserted

Literature

No information inserted

Examination and completion

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

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.

Opportunity to complete the requirements via supplementary examination

No information inserted

Opportunity to raise an approved grade via renewed examination

No information inserted

Examiner

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

Main field of study

Medical Engineering

Education cycle

First cycle

Add-on studies

No information inserted

Contact

Fernando Seoane Martinez (fsm@kth.se)