Tesi etd-09192023-162117 |
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Tipo di tesi
Tesi di laurea magistrale
Autore
CASINI, GAIA
URN
etd-09192023-162117
Titolo
Development of a Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) Regulatory Strategy and related QMS documentation dossier for novel 3D-printed resorbable scaffolds manufactured by BellaSeno in accordance with ISO 13485, ISO 20416 and EU MDR
Dipartimento
INGEGNERIA DELL'INFORMAZIONE
Corso di studi
INGEGNERIA BIOMEDICA
Relatori
relatore Prof. Vozzi, Giovanni
supervisore Dott. Chhaya, Mohit Prashant
supervisore Dott. Chhaya, Mohit Prashant
Parole chiave
- quality management system
- class III implantable custom made medical device
- post market surveillance
- post market clinical follow up
Data inizio appello
06/10/2023
Consultabilità
Non consultabile
Data di rilascio
06/10/2093
Riassunto
The aim of this work thesis was the development of the Post Market Surveillance (PMS) and Post Market Clinical Follow up (PMCF) documentation dossier for BellaSeno 3D printed PCL custom-made Class III medical devices (CMDs). The dossier generated is constituted by a PMS Standard Operating Procedure (SOP), templates and forms, and was integrated into BellaSeno’s Quality Management System (QMS). The documentation developed within this work thesis was necessary to reach the market access authorization. This is accomplished confirming the safety and performance of the device throughout its expected lifetime while maintaining the compliance with EU MDR 2017/745 and the relevant international standards.
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