Skip to main content

HL2014 Safe Medical Devices 7.5 credits

Choose semester and course offering

Choose semester and course offering to see current information and more about the course, such as course syllabus, study period, and application information.


For course offering

Autumn 2024 Start 26 Aug 2024 programme students

Application code


Headings with content from the Course syllabus HL2014 (Autumn 2024–) are denoted with an asterisk ( )

Content and learning outcomes

Course contents

Regulatory aspects: Legal prerequisites, safety, responsibilities, directives dealing with medical devices, standardization, clinical trials as a tool for demonstrating safety and efficacy, harmonization, certification and testing, product classes for devices and how to place a new product on the market. Quality: Quality as a working tool, total quality management (TQM), quality system. Safety and risk analysis. Development of quality system in industries/organizations, providing services/products for assurance that safe and efficient product reach the market.

Intended learning outcomes

The main objective with this course is to give the student substantial understanding about the regulatory framework for medical devices and how personal protection and intended product performance can be assured by the medical device industry and the health care sector.

After passing the course, the student should be able to:

  • Describe, explain and apply in practical use the regulatory demands for medical devices.
  • Describe the difference between regulatory demands in different countries.
  • Explain the interaction between authorities, regulatory bodies, standardization organizations and industry when placing a medical device on the market.
  • Define quality and explain different methods for assuring quality in an organization or for products or services.
  • Enlarge upon the essential role of risk analysis and quality assurance for the medical device industry.
  • Explain and discuss how standardization development enhances the work in the medical device industry and the health care sector.

Literature and preparations

Specific prerequisites

120 ECTS in natural sciences or technology. 6 ECTS in medicine or medical devices/medical technology. English B/6.

Recommended prerequisites

No information inserted


No information inserted


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


  • RED1 - Examination, 7.5 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.

Approved written examination and approved project work

Opportunity to complete the requirements via supplementary examination

No information inserted

Opportunity to raise an approved grade via renewed examination

No information inserted


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


Adam Darwich (

Supplementary information

Notice that the final schedule is not yet decided and the dates can be changed.

Teaching is performed in the form of lectures, field trips and a project work