CUSTOMIZED ORTHOPEDIC DEVICES: LEGISLATION AND TECHNICAL COLLATING
Teaching aims to teach management of collation mandatory technique for the production and supply of medical devices on measure
AIMS AND LEARNING OUTCOMES
The teaching of the objective of teaching to manage the compulsory technical collation for the production and supply of tailor-made medical devices At the end of the course, the student will be able to know and be able to apply the European legislation relating to the technical sorting of tailor-made medical devices, critically evaluate the risk analysis, classify materials for the construction and recognize the origin for the cards traceability.
The seminar aims to transmit the normative part concerning the figure of the orthopedic technician and of the orthopedic companies. Civil invalidity Prosthesis tariff nomenclator Process of provision of the controls provided by the NHS The legislation on quality certification Directive 93/42 Declaration of conformity of production of tailored devices The CE mark The technical sorting of tailored devices.
slides provided in class
Ricevimento: By appointment by mail Filippo.Allegretti@unige.it
PAOLO LUIGI BISIO (President)
first semester from October to December
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Evaluate the learning of the notions related to the bureaucracy of tailor-made medical devices