Descriptif

The objective of this course is to give an overview of the societal and economic constraints of medical devices. It is divided into three parts.The first part examines several central aspects with respect to the safety and the acceptability of assistive and rehabilitation technologies.The second part presents risk management concepts and techniques for the development of medical robots, more specifically of rehabilitation robots. Study of the economic viability of a project. Medical
economic development: study of the various stages of the development of a device with medical use, the proof of concept in the launch on the market. The last part gives the general principles of clinical research and the statistical basic tools.

Content
Definition and application of basic concepts for risk management: risk, harm, safety, hazard, hazardous
situation, safety integrity, safety integrity level, etc.
Risk analysis methods (Fault Tree Analysis, Failure Mode Effects and Criticality Analysis, HAZOP, etc.) based on
system modeling. Risk reduction techniques for medical robots (Hardware and software fault avoidance
techniques, fault tolerance mechanisms, etc.)
Acceptability and ergonomics of the assistive technologies. Relationship between Assistive Technology and
Inclusive Design.
Clinical trials methodology and protocol design.
Data Analysis, Biostatistics
Engineers, designers and technicians collaboration methodology
Evaluation of a medical product
Certification principles and regulations
Life of the product