Struttura e organizzazione – EN

Structure and organization

The annual Master’s degree has a modular structure which allows participants to personalize their educational path depending on their demands and career objectives. Therefore, there are 3 distinct modules for a total of 60 ECTS which are divided into different thematic blocks:

Medical area

Scientific-technological area

Social, economic, legal area

The postgraduate course provides a flexible organization of lectures both in terms of delivery methods and training program.

  • The courses are held in Italian and they require from a minimum of 10 to a maximum of 20 participants
  • The teaching method is hybrid
  • Attendance at lectures is mandatory for a minimum of 75% of the total number of them

Training modules

MODULE I

HOURS: 375

ECTS: 15

BASIC MODULE

Module I aims to provide specific knowledge and competences (medical, engineering, legal, economic, design skills) on the most innovative and applicative aspects of medical devices. The module aims to develop multidisciplinary skills in the medical, legal, scientific, technological, economic and industrial design sector in order to characterize, manage and develop solutions for an integrated approach to the development, certification and marketing of medical devices.

  • Teaching methodology

    Lectures, exercises, laboratories, seminars, individual study

  • Profit check

    Not present

MODULE II

HOURS: 500

ECTS: 20

ADVANCED MODULE

Module II is divided into 9 Advanced Training Courses (CAFs) focused on emerging and innovative aspects related to the development and marketing of medical devices. Not only are the Advanced Training Courses aimed at students of the postgraduate course, but they are also accessible to first level graduates, Master’s degree graduates and graduates from systems prior to the Ministerial Decree 509/99. The courses will take into consideration various aspects (legal, engineering, medical aspects, as well as methodological and integrated management):

  • Attendance

    Participants will be able to choose the Advanced Training Courses according to their preferences but they need to achieve at least 20 required credits. They can also follow all 9 Advanced Training Courses proposed (equal to 61 ECTS). The Advanced Training Courses are organized in such a way that there is no overlap with each other

  • Teaching methodology

    Lectures, Exercises, Laboratories, Seminars, Individual study (only the practical part, where planned, is carried out in person)

  • Profit verification

    Intermediate tests and any tests aimed at achieving the qualification of Clinical Research Expert on Medical Devices are foreseen

MODULE III

HOURS: 375

ECTS: 15

INTERNSHIP

Module III is focused on “Know How” and it consists of activities tailored to projects for the evaluation and integrated management of medical devices for medical devices manufacturing companies, notified bodies, competent authorities and regulatory agencies, as well as research and development centers that deal with innovation in the medical devices sector.

  • Teaching methodology

    Lectures, Exercises, Seminars, Training internships

  • Profit verification

    A final evaluation at Sapienza University of Rome is planned, Confindustria Dispositivi Medici and partner organizations of the postgraduate course

ADDITIONAL ACTIVITIES

HOURS: 125

ECTS: 5

INSIGHTS

The postgraduate course includes the participation in seminars, conferences, in-depth workshops on specific innovative topics on the management of medical devices and the world of regulation and Advanced Training Courses (in addition to the credits provided for Module II) as a part of the educational offer.

FINAL EVALUATION

HOURS: 125

ECTS: 5

ACHIEVEMENT OF THE TITLE

The Final Evaluation, which is necessary in order to achieve the title, consists in the elaboration and discussion of a technical-experimental thesis on the integrated management of Medical Devices. The final paper will be presented by the candidate in front of the Board of Examiners.