Master in Regulation and Governance of Medical Devices

The second-level Master in Regulation and Governance of Medical Devices is offered by the Department of Pharmacy of the University of Naples Federico II. The programme covers the evaluation, selection, purchase and use of medical devices, with emphasis on vigilance and operational management. From national and European regulations it moves on to clinical application. Medical devices, from prostheses to diagnostic software, are subject to complex rules in Italy and in Europe. The master addresses the whole life cycle, from evaluation to selection, from purchase to use and vigilance, and links regulations to clinical and organisational practice.

The course takes place in person in Naples. The cost indicated is €3,000. A compulsory professional internship is provided. Assessment takes place through oral tests at the end of the modules and an oral final exam, in which an experimental project or thesis is presented. The language is not declared and Italian is presumed. Duration and credits are not stated. The page specifies that the professional internship is compulsory and that there is placement support through academic networks. Assessments are oral at the end of the modules, and the final exam is oral, with the presentation of an experimental project or thesis. Duration and credits are not stated.

The aim is to train highly specialised professionals, able to work in public health systems and in private medical device companies, in compliance, regulatory affairs and quality management roles. Related professions are medical device manager, healthcare quality expert, biomedical engineer, clinical research manager and product manager. The master trains specialists able to work in public health systems and in private device companies, in compliance, regulatory affairs and quality roles. Related professions include medical device manager, quality expert and clinical research manager. The cost is €3,000. Before applying it is advisable to compare this information with that published on the university's official website, which may be more up to date than the page. It is also advisable to contact the department's teaching office to clarify any doubts about attendance, lesson calendar, assessment methods and organisation of the final exam. Those who work should carefully assess the commitment required, in terms of weekly hours and attendance, to understand whether the programme is compatible with other professional or personal commitments. It may also be useful to ask whether information sessions or orientation days are held, in which lecturers present the course and answer candidates' questions.