HL2015 Quality and Regulatory Aspects on Medical Devices 3.0 credits
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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Application
For course offering
Spring 2025 Start 14 Jan 2025 programme students
Application code
60972
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.
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
Equipment
Literature
Kurspärm samt under kursens gång utdelat material. Referenslitteratur och internetkällor meddelas på kursens hemsida före kursstart.
Examination and completion
If the course is discontinued, students may request to be examined during the following two academic years.
Grading scale
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
Opportunity to raise an approved grade via renewed examination
Examiner
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.
Further information
Course room in Canvas
Offered by
Main field of study
Education cycle
Add-on studies
Contact
Supplementary information
Home page of the course: http://130.237.83.53/kurser_kth_ki/kvalitet/default.htm