<div class="csl-bib-body">
<div class="csl-entry">Memarpour, K. (2023). <i>Additively manufactured custom-made Titanium implants and related challenges under the regulation (EU) 2017/745</i> [Diploma Thesis, Technische Universität Wien; Medical University of Vienna]. reposiTUm. https://doi.org/10.34726/hss.2023.103350</div>
</div>
-
dc.identifier.uri
https://doi.org/10.34726/hss.2023.103350
-
dc.identifier.uri
http://hdl.handle.net/20.500.12708/177398
-
dc.description
Abweichender Titel nach Übersetzung der Verfasserin/des Verfassers
-
dc.description.abstract
This diploma thesis addresses additively manufactured custom-made titanium implants with respect to the state of the art of this technology and the related challenges according to the regulation (EU) 2017/745.It starts with an introduction to the legal framework for medical devices and discusses the Medical Device Regulation (EU) 2017/745 and the Austrian Medical Device Act (MPG 2021). In this regard, custom-made devices, which are a particular type of medical devices, are discussed and their regulatory requirements are presented. The analysis of regulatory requirements for custom-made devices shows that fewer requirements are needed if the medical device is intended to be used for one specific patient. The regulatory demand becomes even more reduced when the custom-made device is manufactured and used only within a health institution. To provide regulatory knowledge using a hands-on application about manufacturing custom-made devices within a health institution (Center for Medical Physics and Biomedical Engineering, General Hospital of Vienna), an example of an additively manufactured custom-made subperiosteal implant, designed and printed with the Selective Laser Melting is provided. Throughout the process of manufacturing, relevant regulatory documents and standards are indicated and a standard operating procedure is established for future projects of this kind.
en
dc.language
English
-
dc.language.iso
en
-
dc.rights.uri
http://rightsstatements.org/vocab/InC/1.0/
-
dc.subject
Medizinprodukte
de
dc.subject
Regulatorien
de
dc.subject
Additive Fertigung
de
dc.subject
medical devices
en
dc.subject
regulatory aspects
en
dc.subject
additive manufacturing
en
dc.title
Additively manufactured custom-made Titanium implants and related challenges under the regulation (EU) 2017/745
en
dc.title.alternative
Regulatorische Aspekte additiv hergestellter, personalisierter Implantate unter (EU) 2017/745
de
dc.type
Thesis
en
dc.type
Hochschulschrift
de
dc.rights.license
In Copyright
en
dc.rights.license
Urheberrechtsschutz
de
dc.identifier.doi
10.34726/hss.2023.103350
-
dc.contributor.affiliation
TU Wien, Österreich
-
dc.rights.holder
Khashayar Memarpour
-
dc.publisher.place
Wien
-
tuw.version
vor
-
tuw.thesisinformation
Technische Universität Wien
-
tuw.thesisinformation
Medical University of Vienna
-
dc.contributor.assistant
Moscato, Francesco
-
tuw.publication.orgunit
E308 - Institut für Werkstoffwissenschaft und Werkstofftechnologie