HL2014 Säkra medicintekniska produkter 7,5 hp

Safe Medical Devices

OBS!

Informationen nedan baseras på en kursplan som ännu inte har börjat gälla.

  • Utbildningsnivå

    Avancerad nivå
  • Huvudområde

    Medicinsk teknik
  • Betygsskala

    P, F

Kurstillfällen/kursomgångar

HT19 för programstuderande

HT19 för fristående studerande - Till anmälan

  • Perioder

    HT19 P1 (3,0 hp), P2 (4,5 hp)

  • Anmälningskod

    10115

  • Kursen startar

    2019-08-26

  • Kursen slutar

    2019-12-06

  • Undervisningsspråk

    Engelska

  • Studielokalisering

    KTH Flemingsberg

  • Undervisningstid

    Dagtid

  • Undervisningsform

    Normal

  • Antal platser *

    Max. 7

    *) Vid fler sökande än platser kommer urval att ske.

  • Anmälan

    Fullfölj anmälan för kursen på antagning.se via denna anmälningslänk.
    Observera att anmälan måste slutföras på antagning.se genom egen inloggning.

HT18 för programstuderande

HT18 för fristående studerande

  • Perioder

    HT18 P1 (3,0 hp), P2 (4,5 hp)

  • Anmälningskod

    10108

  • Kursen startar

    2018-08-27

  • Kursen slutar

    2018-12-07

  • Undervisningsspråk

    Engelska

  • Studielokalisering

    Campus Flemingsberg

  • Undervisningstid

    Dagtid

  • Undervisningsform

    Normal

  • Antal platser *

    Max. 10

    *) Vid fler sökande än platser kommer urval att ske.

  • Kursansvarig

    Peta Sjölander <petasj@kth.se>

  • Lärare

    Björn-Erik Erlandsson <beerl@kth.se>

Lärandemål

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.

Kursens huvudsakliga innehåll

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.

Behörighet

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 knowledge in English corresponding to English B/English 6

Litteratur

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

Examination

  • RED1 - Tentamen och projektarbete, 7,5, betygsskala: P, F

Approved written examination and approved project work

Ges av

CBH/Medicinsteknik och hälsosystem

Kontaktperson

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

Examinator

Peta Sjölander <petasj@kth.se>

Övrig 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

Versionsinformation

Kursplan gäller från och med HT2019.
Examinationsinformation gäller från och med VT2019.