CUSTOMIZED ORTHOPEDIC DEVICES: LEGISLATION AND TECHNICAL COLLATING

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Code
74362
ACADEMIC YEAR
2020/2021
CREDITS
1 credit during the 3nd year of 9297 ORTHOPAEDIC TECHNIQUES (L/SNT3) GENOVA
LANGUAGE
Italian
TEACHING LOCATION
GENOVA (ORTHOPAEDIC TECHNIQUES)
semester
1° Semester
modules
This unit is a module of:
Teaching materials

AIMS AND CONTENT

LEARNING OUTCOMES

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.

TEACHING METHODS

Frontal lessons

SYLLABUS/CONTENT

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.

RECOMMENDED READING/BIBLIOGRAPHY

slides provided in class

TEACHERS AND EXAM BOARD

Office hours: By appointment by mail Filippo.Allegretti@unige.it

Exam Board

PAOLO LUIGI BISIO (President)

ENRICO MAZZINO

LUIGI MOLFETTA

FILIPPO ALLEGRETTI (President and Coordinator of Integrated Course)

LESSONS

TEACHING METHODS

Frontal lessons

LESSONS START

first semester from October to December

EXAMS

EXAM DESCRIPTION

Oral

ASSESSMENT METHODS

Evaluate the learning of the notions related to the bureaucracy of tailor-made medical devices

Exam schedule

Date Time Location Type Notes
18/01/2021 14:30 GENOVA Orale
22/02/2021 14:30 GENOVA Orale
07/06/2021 14:30 GENOVA Orale
12/07/2021 14:30 GENOVA Orale
13/09/2021 14:30 GENOVA Orale