HL2014 Säkra medicintekniska produkter 7,5 hp

Utbildningsnivå	Avancerad nivå	Kursnivå (A-D)	D
Huvudområde	Medicinsk teknik	Betygsskala	P, F

• Kurssida på KTH Social

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 hp, betygsskala: P, F

Approved written examination and approved project work

Ges av

STH/Medicinsk Teknik

Kontaktperson

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

Examinator

Lars-Gösta Hellström <lars-gosta.hellstrom@sth.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 giltig från och med HT13.
Examinationsinformation giltig från och med HT08.