ETD

Archivio digitale delle tesi discusse presso l’Università di Pisa

Tesi etd-09192023-162117

Tipo di tesi

Tesi di laurea magistrale

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

Parole chiave

class III implantable custom made medical device
post market clinical follow up
post market surveillance
quality management system

Data inizio appello

06/10/2023

Consultabilità

Non consultabile

Data di rilascio

06/10/2093

Riassunto (Inglese)

Riassunto (Italiano)

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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