Dispositivos Médicos (Fcul)
6 ECTSS2Exam: Not specified
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--Description
Objectives
A - Identify and describe the main aspects related to the creation (project), evaluation and regulation of medical devices using, in particular, international standards. B - Identify the main regulatory actors in the medical device market. C – Obtain a critical understanding of the modes of intellectual property protection in the context of the device doctor. D - Identify critical aspects
Syllabus
1 - Reliability of Medical Devices. 2 - Regulation and standards. 3 - Principles of specification and design of a medical device. 4 - Topics on testing and analyzing medical devices. 5 - Controls of production processes and maintenance of medical devices. 6 - Protection of Intellectual Property.
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