HL2015 Quality and Regulatory Aspects on Medical Devices 3.0 credits

Kvalitet och regelverk för medicintekniska produkter

This course provides knowledge about the European regulatory framework concerning medical devices, and how this effects the work with such devices and other related activities in hospitals and industry. In addition, the course provides the corresponding knowledge about quality management of medical devices in hospitals and industry. If you plan to work with medical engineering, this course is strongly recommended.

  • Education cycle

    Second cycle
  • Main field of study

    Electrical Engineering
  • Grading scale

    A, B, C, D, E, FX, F

Course offerings

Spring 19 for programme students

Spring 20 for programme students

  • Periods

    Spring 20 P3 (1.5 credits), P4 (1.5 credits)

  • Application code


  • Start date


  • End date


  • Language of instruction


  • Campus

    KTH Flemingsberg

  • Tutoring time


  • Form of study


  • Number of places

    No limitation

  • Part of programme

Intended learning outcomes

To give sufficient knowledge about the legal requirements for medical devices, and the methods used to safeguard the intention of these requirements to somebody, planning a career in the medical engineering field. To write a technical report.

Course main content

The quality assurance discussion includes quality systems like total quality management (TQM), the ISO 9000 series, Good laboratory practice (GLP), Good manufacturing practice (GMP) and Quality system regulation (QSR). Also methods to assess the reliability of medical devices and aspects on organization are addressed.

The regulatory aspects includes international standards, European and American directives and regulations, clinical trials, laboratory testing, and the certification and accreditation instruments.

The issues of responsibility, safety and ethics in health care and clinical trials are addressed specifically.


Two years of undergraduate studies in Natural Sciences or Engineering, and knowledge of Medical Engineering corresponding to HL1007 Medical Engineering, Basic Course http://www.kth.se/student/kurser/kurs/HL1007 l=en_UK

Documented proficiency in Swedish corresponding to Swedish B/Swedish 3 and English corresponding to English A/ english 6.


Kurspärm samt under kursens gång utdelat material. Referenslitteratur och internetkällor meddelas på kursens hemsida före kursstart.


  • INL1 - Assignment, 3.0, grading scale: A, B, C, D, E, FX, F

Requirements for final grade

A written report.

Offered by

CBH/Biomedical Engineering and Health Systems


Lars Gösta Hellström, gosta.hellstrom@ki.se


Lars Gösta Hellström <lghe@kth.se>

Supplementary information

Home page of the course:


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