Skip to main content
Till KTH:s startsida

CM204V Quality Managment Systems and Regulatory Framework in Clinical Engineering 5.0 credits

Patient safety and good quality of care are strongly linked to the processes used in healthcare. The use of technology, new or old, has been part of healthcare for decades, and medical applications have been the driving force behind developing new technologies. The regulatory framework for the use and management of technology in healthcare is extensive and knowledge of these requirements and their application in practical medical devices is necessary in modern healthcare.

Information per course offering

Termin

Information for Autumn 2024 Start 28 Oct 2024 single courses students

Course location

KTH Flemingsberg

Duration
28 Oct 2024 - 13 Jan 2025
Periods
P2 (5.0 hp)
Pace of study

25%

Application code

10087

Form of study

Normal Daytime

Language of instruction

English

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 CM204V (Autumn 2024–)
Headings with content from the Course syllabus CM204V (Autumn 2024–) are denoted with an asterisk ( )

Content and learning outcomes

Course contents

The course includes a review of the following contents:

  • applicable European directives, national laws, regulations and directions including MDR
  • liability issues
  • applicable standards
  • the concept of quality
  • quality management system for medical technology operations
  • patient safety when using medical devices
  • handling accidents and incidents
  • adverse event analysis
  • risk management in the use and handling of medical devices

Intended learning outcomes

After completion, the participant will be able to:

  • analyse the current regulatory framework for medical technology operations in detail
  • identify the necessary parts in a quality management system
  • give details for developing a quality management system for medical technology operations
  • identify critical risks in medical technology operations

Literature and preparations

Specific prerequisites

120 credits in technical, natural or medical sciences or in human resource studies. Alternatively, 2 years of professional experience in health/medical care.

Recommended prerequisites

No information inserted

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, 5.0 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

Second cycle

Add-on studies

No information inserted

Contact

Fernando Seoane Martinez (fsm@kth.se)