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Overview
What you will learn
After passing the Safe Medical Devices course offered by KTH Royal Institute of Technology, 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.
Programme Structure
The program focuses on:
- 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.
Key information
Duration
- Full-time
- 5 months
Start dates & application deadlines
- Starting
- Apply before
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Language
English
TOEFL® IBT 90
Credits
7 ECTS
Delivered
On Campus
Disciplines
Occupational Health and Safety View 9 other Short Courses in Occupational Health and Safety in SwedenAcademic requirements
We are not aware of any specific GRE, GMAT or GPA grading score requirements for this programme.
English requirements
TOEFL® IBT 90
Student insurance
Make sure to cover your health, travel, and stay while studying abroad. Even global coverages can miss important items, so make sure your student insurance ticks all the following:
- Additional medical costs (i.e. dental)
- Repatriation, if something happens to you or your family
- Liability
- Home contents and baggage
- Accidents
- Legal aid
We partnered with Aon to provide you with the best affordable student insurance, for a carefree experience away from home.
Get your student insurance nowStarting from €0.53/day, free cancellation any time.
Remember, countries and universities may have specific insurance requirements. To learn more about how student insurance work at KTH Royal Institute of Technology and/or in Sweden, please visit Student Insurance Portal.
Other requirements
General requirements
- At least 120 credits of science studies at university level .
- 6 credits in medicine and medical engineering in accordance with the course HL1007 Medical engineering, basic course.
- Knowledge in English corresponding to English B/English 6.
Tuition Fee
To always see correct tuition fees
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EU/EEA
FreeTuition FeeBased on the tuition of 0 SEK for the full programme during 5 months.
If you are an EU, EEA or Swiss citizen or hold a residence permit in Sweden for something other than studies you generally do not have to pay tuition fees.
Living costs for Stockholm
9668 - 17248 SEK /month
Living costs
The living costs include the total expenses per month, covering accommodation, public transportation, utilities (electricity, internet), books and groceries.
Funding
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