From prototype to product, from a CE perspective, 3.5 Credits

Contents

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 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 modules: 
1. Theory 2.5 ECTS 
2. Case seminars 1 ECTS

Expected learning outcomes

The student must be 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.

Required Knowledge

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/6. 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 campusbased and 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. Teaching can take place in English.
 

Examination modes

Module 1: Theory 2.5 credits 
This module is examined with a written individual home examination and/or report. The grade Fail (U), Pass (G) or Pass with Distinction (VG) is set. 
 
Module 2: Case seminars 1 credits. 
This module 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 (G) or Pass with distinction (VG) are set. To pass the course it is required that all examinations and obligatory tasks are approved. The grade is based on the grade obtained on module 1 and is only given when all mandatory modules have been approved.

A student who has received a passing result on an exam may not take a new exam.

The examiner can decide on deviations from the examination form of the syllabus. Individual adaptation of the form of examination must be considered based on the student's needs. The form of the examination is adapted within the framework of the curriculum's expected study results. A student who needs an adapted examination, and who has received a decision on the right to support from the coordinator for students with disabilities at the Student Centre, must request adaptation from the department responsible for the course no later than 10 days before the examination. The examiner decides on an adapted examination, which is then notified to the student.

Other regulations

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.