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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
- StartingApplication deadline not specified.
Language
English
TOEFL® IBT OR
90
IELTS 6.5
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Credits
7 ECTS
7.5 credits
Delivered
On Campus
Campus Location
- Stockholm, Sweden
Disciplines
Occupational Health and Safety View 11 other Short Courses in Occupational Health and Safety in SwedenWhat students do after studying
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Academic requirements
We are not aware of any specific GRE, GMAT or GPA grading score requirements for this programme.
English requirements
TOEFL® IBT OR
90
IELTS 6.5
Prepare for Your English Test
Cathoven AI IELTS Preparation AI-powered IELTS feedback. Clear, actionable, and tailored to boost your writing & speaking score. No credit card or upfront payment required.
- Trusted by 300k learners
- 98 accuracy using real exam data
- 4.9/5 student rating
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.
Student Insurance via Studyportals Partner
Make sure to cover your health, travel, and stay while studying abroad. Even global coverages can miss important items like Additional medical costs, Repatriation, Liability etc. Make sure your student insurance covers your needs.
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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.
Tuition Fees
Living costs
Stockholm
Sweden
9668 - 17248 SEK / month
The living costs include the total expenses per month, covering accommodation, public transportation, utilities (electricity, internet), books and groceries.
Funding
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