HL2014 Safe Medical Devices 7.5 credits

Säkra medicintekniska produkter

  • Education cycle

    Second cycle
  • Main field of study

    Medical Engineering
  • Grading scale

    P, F

Course offerings

Autumn 19 for programme students

Autumn 18 for programme students

Autumn 18 for single courses students

  • Periods

    Autumn 18 P1 (3.0 credits), P2 (4.5 credits)

  • Application code


  • Start date


  • End date


  • Language of instruction


  • Campus

    KTH Flemingsberg

  • Tutoring time


  • Form of study


  • Number of places *

    Max. 10

    *) If there are more applicants than number of places selection will be made.

  • Course responsible

    Peta Sjölander <petasj@kth.se>

  • Teacher

    Björn-Erik Erlandsson <beerl@kth.se>

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.

Course main content

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.


At least two years of science studies at university level . Basic knowledge in medicine and medical engineering in accordance with the course HL1007 Medical engineering, basic course and and knowledge in English corresponding to English B/English 6.


Course literature see literature list. Reference literature and internet sites will be informed on the course website before course start


  • RED1 - Examination, 7.5, grading scale: P, F

Approved written examination and approved project work

Offered by

CBH/Biomedical Engineering and Health Systems


Björn-Erik Erlandsson, bjorn-erik.erlandsson@sth.kth.se


Peta Sjölander <petasj@kth.se>

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


Course syllabus valid from: Autumn 2013.
Examination information valid from: Spring 2019.