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.

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Course information

Content and learning outcomes

Course contents *

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.

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 Disposition

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Literature and preparations

Specific prerequisites *

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.

Recommended prerequisites

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Equipment

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Literature

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

Examination and completion

Grading scale *

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

Examination *

  • INL1 - Assignment, 3.0 credits, Grading scale: A, B, C, D, E, FX, 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.

Other requirements for final grade *

A written report.

Opportunity to complete the requirements via supplementary examination

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Opportunity to raise an approved grade via renewed examination

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Examiner

Mats Nilsson

Further information

Course web

Further information about the course can be found on the Course web at the link below. Information on the Course web will later be moved to this site.

Course web HL2015

Offered by

CBH/Biomedical Engineering and Health Systems

Main field of study *

Electrical Engineering

Education cycle *

Second cycle

Add-on studies

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Contact

Lars Gösta Hellström, gosta.hellstrom@ki.se

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.

Supplementary information

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