This subject, which is part of the core module of the Master in Biomedical Engineering, focuses its objectives on the training related to the fulfilment of the necessary requirements for the professional use of a medical device. For this purpose, two main blocks of content are developed to cover the regulatory framework in which the medical device may be developed after its design.
In the first block, the certification process of sanitary products will be studied, describing their classification, analysis and implementation. All the regulations involved in this process will be considered, from the implementation of a quality management system to compliance with the precise regulations.
Then, in the second block, a generalized study of the industrial and intellectual protection process will be addressed, analyzing their respective characteristics and functions, reviewing the concepts, regulations and legislation in this regard, and also analyzing both the precise requirements for applying for a patent or utility model, as well as the procedure to be followed.
Finally, and because of the processes described above, the process of innovation and entrepreneurship in biomedical engineering will be defined, contextualized and discussed.
At the end of the course, the student should have sufficient skills and competences to understand the processes involved in the innovation of medical devices, to develop the procedure for the intellectual and industrial protection of these products and, in addition, to certify them appropriately and normatively for their end use.
