| Course label : | BME103 Industry of Biomedical devices |
|---|---|
| Teaching departement : | MSO / Structures, Mechanisms and Construction |
| Teaching manager : | Mister OLIVIER MAYEUR |
| Education language : | |
| Potential ects : | 1 |
| Results grid : | |
| Code and label (hp) : | MR_BME_S1_MSO_IBD - BME103 Ind.of Biomed.devices |
Education team
Teachers : Mister OLIVIER MAYEUR
External contributors (business, research, secondary education): various temporary teachers
Summary
Medical device in EU: design, develop, and certify. What is this industry, where, who. Discovering the Biomedical industry, their challenge, major companies, market and unployment opportunities. Chapter1: Introduction What is a medical device ? Introduction to the European medical device regulation MDR 2017/745. Qualification and Classification of a MD : Importance of the Intended Use Chapter 2: Design a medical device Introduction to Quality Management System ISO, Design and develop according to ISO Chapter 3: Develop a medical device - Annex I of MDR: General Safety and Performance Requirements, - Main applicable standards (Risk Analysis, Electromedical devices, Software in MD, Biocompatibility,…) - Clinical evaluation - Verification and Validation Chapter 4: Certify a MD Annex II of MDR: Technical Documentation, Notified Body and certification
Educational goals
This course combines lectures, demonstrations, discussions and problem solving exercises exploring design of medical devices. Emphasis on manufacturing skills and design for manufacturing and assembly.
Sustainable development goals
Knowledge control procedures
Final Exam
Comments:
Online resources
Pedagogy
The acquisition of knowledge will follow a red thread that will allow the student to assimilate all the different steps of the methodology. Theoretical results will be confronted with mechanical tests in order to verify their adequacy. Following this knowledge acquisition, students will have to solve an industrial problem in project mode.
Sequencing / learning methods
| Number of hours - Lectures : | 0 |
|---|---|
| Number of hours - Tutorial : | 0 |
| Number of hours - Practical work : | 0 |
| Number of hours - Seminar : | 15 |
| Number of hours - Half-group seminar : | 0 |
| Number of student hours in TEA (Autonomous learning) : | 0 |
| Number of student hours in TNE (Non-supervised activities) : | 0 |
| Number of hours in CB (Fixed exams) : | 0 |
| Number of student hours in PER (Personal work) : | 0 |
| Number of hours - Projects : | 0 |