Duration
20h Th, 10h Pr
Number of credits
| Master in biomedicine (120 ECTS) | 3 crédits |
Lecturer
Language(s) of instruction
English language
Organisation and examination
Teaching in the first semester, review in January
Schedule
Units courses prerequisite and corequisite
Prerequisite or corequisite units are presented within each program
Learning unit contents
Medical device means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purposes of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury.
According to the risk related to the device, clinical trial must be achieved to assess safety and efficacy. Conception of such trials must go through a number of steps, like pharmaceutical devices, complying with the applicable legal and regulatory requirement and ethics.
The aim is to understand how and why a clinical trial on a medical device is achieved.
Tables of contents:
1. Definition
2. Classification of medical devices
3. Classification of clinical trials
4. Conception/security
Cost/efficacy ratio
Data management
Human beings protection
5. Rules and regulation
Learning outcomes of the learning unit
The aim is to understand how and why a clinical trial on a medical device is achieved.
Prerequisite knowledge and skills
Planned learning activities and teaching methods
Interactive lectures
Mode of delivery (face-to-face ; distance-learning)
Mode of delivery: face-to-face and distance-learning
Recommended or required readings
Assessment methods and criteria
Oral examination
Work placement(s)
Organizational remarks
Languages: English and/or French