HL2014 Safe Medical Devices 7.5 credits
Säkra medicintekniska produkter
Please note
The information on this page is based on a course plan that is not yet valid.
| Educational level | Second cycle | Academic level (A-D) | D |
| Subject area |
Medical Engineering |
Grade scale | P, F |
Course offerings
Autumn 12 for single courses students
| Periods Autumn 12 | P1 (7.5 credits) | Application code | 10082 |
| Start date | 24/08/2012 | End date | 2012 week: 48 |
| Language of instruction | English | Campus | KTH Flemingsberg |
| Number of lectures | Number of exercises | ||
| Tutoring time | Daytime | Form of study | Normal |
| Number of places * | 1 - 10 | ||
| *) The Course date may be cancelled if number of admitted are less than minimum of places. If there are more applicants than number of places selection will be made. | |||
| Course responsible |
Björn-Erik Erlandsson <bjorn-erik.erlandsson@sth.kth.se>
|
||
Autumn 12 for programme students
| Periods Autumn 12 | P1 (7.5 credits) | Application code | 51443 |
| Start date | 2012 week: 34 | End date | 2012 week: 48 |
| Language of instruction | English | Campus | KTH Flemingsberg |
| Number of lectures | Number of exercises | ||
| Tutoring time | Daytime | Form of study | Normal |
| Number of places | No limitation | ||
| Course responsible |
Björn-Erik Erlandsson <bjorn-erik.erlandsson@sth.kth.se>
|
||
| Part of programme | |||
Autumn 13 for single courses students - To application
| Periods Autumn 13 | P1 (7.5 credits) | Application code | 10057 |
| Start date | 02/09/2013 | End date | 2013 week: 44 |
| Language of instruction | English | Campus | KTH Flemingsberg |
| Number of lectures | Number of exercises | ||
| Tutoring time | Daytime | Form of study | Normal |
| Number of places * | 1 - 15 | ||
| *) The Course date may be cancelled if number of admitted are less than minimum of places. If there are more applicants than number of places selection will be made. | |||
| Course responsible |
Björn-Erik Erlandsson <bjorn-erik.erlandsson@sth.kth.se>
|
||
|
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. |
|||
Autumn 13 for programme students
| Periods Autumn 13 | P1 (7.5 credits) | Application code | 50138 |
| Start date | 2013 week: 36 | End date | 2013 week: 44 |
| Language of instruction | English | Campus | KTH Flemingsberg |
| Number of lectures | Number of exercises | ||
| Tutoring time | Daytime | Form of study | Normal |
| Number of places | No limitation | ||
| Course responsible |
Björn-Erik Erlandsson <bjorn-erik.erlandsson@sth.kth.se>
|
||
| Part of programme | |||
Learning outcomes
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.
Course main content
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.
Eligibility
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 and knowledge in English corresponding to English B/English 6.
Literature
Course literature see literature list. Reference literature and internet sites will be informed on the course website before course start
Examination
- RED1 - Examination, 7.5 credits, grade scale: P, F
Approved written examination and approved project work
Offered by
STH/Medcial Technology
Contact
Björn-Erik Erlandsson, bjorn-erik.erlandsson@sth.kth.se
Examiner
Lars-Gösta Hellström <lars-gosta.hellstrom@sth.kth.se>
Supplementary 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
Version
Course plan valid from:
Autumn 13.
Examination information valid from:
Autumn 08.