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Dettaglio Insegnamento
| Anno Accademico |
2021/2022 |
| Corso di Studi |
Dott. - MI (1373) Bioingegneria / Bioengineering |
| Anno di Corso |
1 |
| Codice Identificativo |
057401 |
| Denominazione Insegnamento |
EUROPEAN MEDICAL DEVICE REGULATION AND CLINICAL INVESTIGATIONS |
| Tipo Insegnamento |
MONODISCIPLINARE |
| Crediti Formativi Universitari (CFU) |
5.0 |
| Programma sintetico |
MISSION AND GOALS
In the recent years, technical universities, including Politecnico di Milano, have been strongly supporting technology transfer processes (c.f. Switch2Product), resulting in an increasing number of patents and start-ups, which are becoming a concrete option for the career of our PhD students. In this context, we believe that it is crucial to include a Course on European Medical Devices Regulation and clinical investigations in our PhD program. The objective of this course will be to provide an introduction to the Medical
Device Regulation (MDR 2017/745) which has recently updated the rules concerning the placing on the market of medical devices for human use. The course will include lectures on regulatory pathways, technical documentation, clinical evaluations and investigations.
SUBJECT AND PROGRAMME OF THE COURSE
The Regulatory Affairs for Medical Devices are in a transitional period. With the increased focus on patient safety, the European MDR 2017/745, which was officially published on May 5th 2017 and will be fully applied from May 26th 2021, has introduced many changes to the requirements and processes involved. This course will provide an overview of MDR 2017/745, starting from the regulatory pathways, introducing the rules for medical devices classification. It will describe the technical documentation, including the risk management file, which is required to apply for the CE mark. A specific section will be dedicated to the Medical Device Software Qualification and Classification, being software intended to process, analyse, create or modify medical information qualified as a medical device. New requirements for pre-market (to generate clinical data in support of safety and/ or clinical performance for CE marking) and postmarket clinical investigations (to maintain CE mark) under MDR 2017/745 will be also described. The five stages of clinical evaluation (i.e. definition of objective, data collection, appraisal, analysis and report) will be introduced. Finally, an introduction to clinical trials as instruments to translate evidence into clinical practice (with a specific focus to the rehabilitative context) will be provided. Case studies presented by medical device experts and a round table including both industrial and technical prospective, will complete the course. |
| Settori Scientifico Disciplinari (SSD) |
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Scaglione
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Docente
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Programma dettagliato
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Da (compreso)
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A (escluso)
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A
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ZZZZ
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Ambrosini Emilia, Caiani Enrico Gianluca, Pedrocchi Alessandra Laura Giulia, Redaelli Alberto Cesare Luigi, Villa Tomaso Maria Tobia
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