Revised by: Faculty Board of Science and Technology, 2020-11-05
Contents All companies that sell products on the European market must ensure that their products meet the EU requirements in the EU country where the product is to be sold, to protect human and animal health, the environment and consumer rights. CE marking of a product is required when selling products in the EU. This marking indicate that the product has been assessed by the manufacturer to meet these requirements. The course gives, among other things, an overview of how a company can proceed to meet the requirements set for the development of medical devices.
The course provides a better overall picture of the basics of CE marking as well as an increased knowledge of product responsibility and product safety. The course also provides an insight into the complex product area medical devices. The course includes compulsory case seminars.
The course consists of two parts: 1. Theory 2.5 ECTS 2. Case seminars 1 ECTS
Expected learning outcomes
Expected learning outcomes
After completing the course, students are able to:
Knowledge and understanding Thoroughly describe the general product safety directive. Critically describe why the CE marking requirement exists and what it means. Explain in detail the documents needed for CE marking. Thoroughly describe the development process, from prototype production to finished product.
Competence and skills Independently apply the process for CE marking. Demonstrate the ability to work in groups in connection with project work and case seminars.
Judgement and approach Critically evaluate a sustainable business approach linked to the productization of a product.
At least 90 credits completed a three-year engineering degree, or at least 90 credits in one of the main areas of Computer Science, Electronics, Physics, Chemistry, Mathematics or Mathematical Statistics. Proficiency in English equivalent to Swedish upper secondary course English A/5. Where the language of instruction is Swedish, applicants must prove proficiency in Swedish to the level required for basic eligibility for higher studies.
Form of instruction
The teaching is conducted in the form of lectures and case seminars. Participation in case seminars is mandatory. It takes place on campus but digital learning methods are offered.
Part 1: Theory 2.5 credits This part is examined with a written individual home examination and/or report. The grade Fail (U), Pass (3), Pass with Credit (4) or Pass with Distinction (5) is set.
Part 2: Case seminars 1 credits. This part is examined with oral and written presentations of the case reports. The grade Fail (U) or Pass (G) is set.
On the whole course the grades Fail (U), Pass (3), Pass with merit (4) or Pass with distinction (5) are set. To pass the course it is required that all examinations and obligatory tasks are approved. The grade is then based on the grade received on part 1.
Students who received a passing grade on an examination may not retake the examination.
Students who do not pass the regular examination renewed examination in accordance with the Umeå University Regulations for tests and examinations at the undergraduate and graduate level (FS 1.1.2-553-14) could be arranged. The first re-test is offered not later than two months after the first examination. When the ordinary examination takes place in May or June, d a first retesting opportunity is given within three months after the first examination. In addition, at least another re-test within one year of regular examination is offered.
In cases where the exam cannot be repeated under the current rules for retesting the exam should instead be replaced with another task. The scope and content of such task should not be disproportionate to the missed exam.
A student who has taken two examinations in a course or part of a course without passing, has the right to have another examiner appointed, unless there are specific reasons against it (6 ch. 22, § HF). Requests for new examiners should be addressed to the head of the Department of Radiation Sciences.
In the event that the course expires or major changes are introduced, the students are assured at least three occasions of examination (including regular examination) as prescribed in the syllabus to the course that the student originally registered in over a period of a maximum of two years from the previous syllabus expired.