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

Administer About course

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

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 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.

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, 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.

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

Examiner

Profile picture Mikael Forsman

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

Second cycle