The course syllabus contains changes
See changesCourse syllabus adopted 2024-03-01 by Head of Programme (or corresponding).
Overview
- Swedish nameUtveckling av medicintekniska produkter
- CodeEEN040
- Credits7.5 Credits
- OwnerMPMED
- Education cycleSecond-cycle
- Main field of studyElectrical Engineering
- DepartmentELECTRICAL ENGINEERING
- GradingTH - Pass with distinction (5), Pass with credit (4), Pass (3), Fail
Course round 1
- Teaching language English
- Application code 41111
- Maximum participants50 (at least 10% of the seats are reserved for exchange students)
- Minimum participants5
- Block schedule
- Open for exchange studentsYes
Credit distribution
Module | Sp1 | Sp2 | Sp3 | Sp4 | Summer | Not Sp | Examination dates |
|---|---|---|---|---|---|---|---|
| 0119 Project 6 c Grading: TH | 6 c | ||||||
| 0219 Laboratory 1.5 c Grading: UG | 1.5 c |
In programmes
- MPMED - BIOMEDICAL ENGINEERING, MSC PROGR, Year 1 (compulsory elective)
- MPMED - BIOMEDICAL ENGINEERING, MSC PROGR, Year 2 (elective)
Examiner
Giacomo Valle- Assistant Professor, Systems and Control, Electrical Engineering
Eligibility
General entry requirements for Master's level (second cycle)Applicants enrolled in a programme at Chalmers where the course is included in the study programme are exempted from fulfilling the requirements above.
Specific entry requirements
English 6 (or by other approved means with the equivalent proficiency level)Applicants enrolled in a programme at Chalmers where the course is included in the study programme are exempted from fulfilling the requirements above.
Course specific prerequisites
The course Biomedical Instrumentation or equivalent.Aim
This course aims to provide specific knowledge in the ideation, creation, and certification of medical devices including product development procedures.Learning outcomes (after completion of the course the student should be able to)
- explore the implementation of technologies within the field of medicine with regard to relevant scientific, social and ethical aspects;
- classify a medical device according to European and USA regulations;
- implement a verification and validation plan for a medical device;
- judge which type of tests that are needed for verification and validation of a medical device;
- perform risk assessments of medical devices;
- implement projects which meet the technical and safety requirements of medical devices and demonstrate awareness of ethical aspects in research and development;
- confront criteria in the decision-making process, and make judgements from information which may be incomplete or limited within the field of biomedical engineering;
- apply previously developed knowledge and skills to work with engineering solutions in medicine by critically examining ethical, legal, and social aspects including equal treatment and gender equality;
- identify value creation for external stakeholders;
- seek and acquire information from relevant scientific publications when working in a project team;
- in oral presentations and written report in English, describe a medical device development process; and
- reflect on own and other's abilities and roles in relation to project work;
- understand the concepts and measurement of equity in healthcare.
Content
The student will learn how to create a medical device from ideation to validation. Development of Medical Devices with aspects on: product development procedures, certification (risk assessment and classification according to applicable regulatory requirements), verification with different types of tests (life time estimation, electromagnetic radiation, diagnostic accuracy, etc), and validation with clinical studies.This course is based on experiential learning. It means that i) the students are actively influencing and managing their projects, ii) the course has an explicit focus on the students¿ capabilities and working methods, and iii) the learning activities aim to simulate a real project with real problems as much as possible.
This is a project-based course. Students will take an idea for a medical device through the process of developing it into a potential product, however they will not be making or building the device or any part of it. Students are encouraged to explore their own ideas for the development of a medical device. If they do not have their own ideas, case studies/projects will be provided.
Organisation
The course will contain lectures, project work and laboratory sessions.There will be 3 lectures per week. New concepts will be introduced by guest lecturers from industry in the first 2 lectures (Tuesdays and Wednesdays), and students will present the application of such concepts to their project in the 3rd lecture (Fridays).