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HL2015 Quality and Regulatory Aspects on Medical Devices 3.0 credits

Kvalitet och regelverk för medicintekniska produkter

Please note

The information on this page is based on a course plan that is not yet valid.

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.

  • Educational level

    Second cycle

  • Academic level (A-D)

    D

  • Subject area

    Electrical Engineering

  • Grade scale

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

Course offerings

Spring 14 for programme students

  • Periods

    Spring 14 P3 (1.5 credits), P4 (1.5 credits)

  • Application code

    60432

  • Start date

    2014 week: 4

  • End date

    2014 week: 23

  • Language of instruction

    Swedish

  • Campus

    KTH Flemingsberg

  • Number of lectures

  • Number of exercises

  • Tutoring time

    Daytime

  • Form of study

    Normal

  • Number of places

    No limitation

  • Target group

    CMEDT3

  • Part of programme

Spring 14 for single courses students - To application

  • Periods

    Spring 14 P3 (1.5 credits), P4 (1.5 credits)

  • Application code

    20038

  • Start date

    03/02/2014

  • End date

    2014 week: 23

  • Language of instruction

    Swedish

  • Campus

    KTH Flemingsberg

  • Number of lectures

  • Number of exercises

  • Tutoring time

    Daytime

  • Form of study

    Normal

  • Number of places *

    Max. 7

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

  • Application

    Apply for this course at antagning.se through this application link.
    Please note that you need to log in at antagning.se to finalize your application.

Spring 13 cmedt for programme students

  • Periods

    Spring 13 P3 (1.5 credits), P4 (1.5 credits)

  • Application code

    60936

  • Start date

    2013 week: 2

  • End date

    2013 week: 21

  • Language of instruction

    Swedish

  • Campus

    KTH Flemingsberg

  • Number of lectures

  • Number of exercises

  • Tutoring time

    Daytime

  • Form of study

    Normal

  • Number of places

    No limitation

  • Schedule

    Schedule (new window)

  • Part of programme

Spring 13 for single courses students

  • Periods

    Spring 13 P3 (1.5 credits), P4 (1.5 credits)

  • Application code

    20061

  • Start date

    11/02/2013

  • End date

    2013 week: 21

  • Language of instruction

    Swedish

  • Campus

    KTH Flemingsberg

  • Number of lectures

  • Number of exercises

  • Tutoring time

    Daytime

  • Form of study

    Normal

  • Number of places *

    Max. 10

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

  • Schedule

    Schedule (new window)

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.

Eligibility

Two years of undergraduate studies in Natural Sciences or Engineering, and knowledge of Medical Engineering corresponding to HL2006 Medical Engineering, Basic Course http://www.kth.se/student/kurser/kurs/HL2006?l=en_UK

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

Literature

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

Examination

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

Requirements for final grade

A written report.

Offered by

STH/Medcial Technology

Contact

Lars Gösta Hellström, gosta.hellstrom@ki.se

Examiner

Lars-Gösta Hellström <lars-gosta.hellstrom@sth.kth.se>

Supplementary information

Home page of the course: http://130.237.83.53/kurser_kth_ki/kvalitet/default.htm

Version

Course plan valid from: Spring 14.
Examination information valid from: Spring 09.