@inproceedings{CarlHochmann2021, author = {Carl, Ann-Kathrin and Hochmann, David}, title = {Regulatory Framework for 3D Printed Custom-Made Devices in Europe}, series = {Beitrag zur 3. Additive Manufacturing Meets Medicine (AMMM) Konferenz}, booktitle = {Beitrag zur 3. Additive Manufacturing Meets Medicine (AMMM) Konferenz}, issn = {2699-1977}, doi = {10.18416/AMMM.2021.2109542}, year = {2021}, abstract = {Additive manufacturing (AM) has been growing continuously over the past 20 years, enabling unprecedented tailoring to the anatomy of each patient. In Europe, custom-made devices qualify for an exemption and pass a simplified approval process. New technologies, like AM, provoke questions about the adequacy of the current regulatory framework for custom-made devices. This article addresses the regulatory requirements for such devices in Europe and discusses the implications for AM. It concludes that the legal framework for custom-made devices entails uncertainties which need to be resolved to guide manufacturers through the regulatory requirements, highlighting the specific areas of focus for AM.}, language = {en} } @article{Carl2021, author = {Carl, Ann-Kathrin}, title = {Ergebnisse einer Umfrage der FH M{\"u}nster. MDR und die Hilfsmittelbranche}, series = {MTD Medizintechnischer Dialog}, volume = {47}, journal = {MTD Medizintechnischer Dialog}, number = {10}, issn = {0935-137X}, pages = {16 -- 18}, year = {2021}, language = {de} } @article{CarlHochmann2021, author = {Carl, Ann-Kathrin and Hochmann, David}, title = {MDR - Wie gut vorbereitet ist die Hilfsmittelbranche?}, series = {mt-medizintechnik}, volume = {141}, journal = {mt-medizintechnik}, number = {2}, issn = {0344-9416}, pages = {34 -- 39}, year = {2021}, abstract = {Im Mittelpunkt der Medizintechnikbranche stand in den letzten Jahren fast ausschließlich ein Thema: die Medical Device Regulation, kurz MDR. Mit Inkrafttreten der MDR steigen die regulatorischen Anforderungen f{\"u}r alle Akteure der Medizintechnikbranche in ganz Europa. Vor allem kleine und mittelst{\"a}ndische Unternehmen werden durch die Implementierung der MDR vor Herausforderungen gestellt. Das Ziel der durchgef{\"u}hrten Online-Befragung war es, ein umfassendes Erfahrungs- und Meinungsbild hinsichtlich der Akzeptanz und Umsetzbarkeit der MDR zu gewinnen. Hierf{\"u}r wurden H{\"a}ndler und Hersteller orthop{\"a}discher Hilfsmittel im Januar und Februar 2021 deutschlandweit anonymisiert befragt. In diesem Artikel werden die Ergebnisse der Umfrage ausf{\"u}hrlich dargestellt und diskutiert.}, language = {de} } @article{HinricherPawelzikBackhaus2021, author = {Hinricher, N. and Pawelzik, L. and Backhaus, C.}, title = {Investigation of Impulse Oscillometry for the Detection of Extravasations using Design of Experiments and an Infusion Simulator}, series = {Medical Engineering and Physics}, volume = {92}, journal = {Medical Engineering and Physics}, number = {19}, issn = {1350-4533}, doi = {10.1016/j.medengphy.2021.04.002}, pages = {33 -- 39}, year = {2021}, language = {en} } @inproceedings{HinricherKoenigBackhaus2021, author = {Hinricher, N. and K{\"o}nig, S. and Backhaus, C.}, title = {Usability-Evaluation von Steuerst{\"a}nden mittels Wizard-of-Oz Methode und Klickdummies am Beispiel eines Prototyps zur Steuerung einer Onshore-Bohranlage}, series = {Beitrag zum 67. Kongress der Gesellschaft f{\"u}r Arbeitswissenschaft}, booktitle = {Beitrag zum 67. Kongress der Gesellschaft f{\"u}r Arbeitswissenschaft}, publisher = {Dortmund}, address = {GfA-Press}, isbn = {978-3-936804-29-4}, pages = {C.3.2}, year = {2021}, language = {de} } @inproceedings{KoenigHinricherBackhaus2021, author = {K{\"o}nig, S. and Hinricher, N. and Backhaus, C.}, title = {Physisches Modell oder virtueller Prototyp? Ein vergleichender Usability-Test am Beispiel eines Blutdruckmessger{\"a}tes}, series = {Beitrag zum 67. Kongress der Gesellschaft f{\"u}r Arbeitswissenschaft}, booktitle = {Beitrag zum 67. Kongress der Gesellschaft f{\"u}r Arbeitswissenschaft}, publisher = {GfA-Press}, address = {Dortmund}, isbn = {978-3-936804-29-4}, pages = {A.7.3}, year = {2021}, language = {de} } @inproceedings{IbenthalKehmannBackhaus2021, author = {Ibenthal, E. and Kehmann, M. and Backhaus, C.}, title = {Arbeitswissenschaftliche Analyse zum Verhalten von Menschen mit Demenz in station{\"a}ren Pflegeeinrichtungen unter Einfluss personalisierter Musik}, series = {Beitrag zum 67. Kongress der Gesellschaft f{\"u}r Arbeitswissenschaft}, booktitle = {Beitrag zum 67. Kongress der Gesellschaft f{\"u}r Arbeitswissenschaft}, publisher = {GfA-Press}, address = {Dortmund}, isbn = {978-3-936804-29-4}, pages = {C.3.1}, year = {2021}, language = {de} } @article{PawelzikBackhaus2021, author = {Pawelzik, L. and Backhaus, C.}, title = {Evaluation of Impuls-Oscillometric Extravasatio Prevention}, series = {Medical Engineering and Physics}, volume = {88}, journal = {Medical Engineering and Physics}, issn = {1350-4533}, doi = {10.1016/j.medengphy.2020.12.004}, pages = {54 -- 58}, year = {2021}, language = {en} } @inproceedings{NguyenMartinaKernagisetal.2021, author = {Nguyen, K. and Martina, S. and Kernagis, D. and Bershad, E. and Clark, J. and Hinricher, N. and Backhaus, C.}, title = {Effekt of repetetive, successive oculometric testing an saccades, smooth pursuit, and visual reaction times for future head down bed rest study (HDBR) applikations}, series = {Contribution to the NASA Online-Conference for Advancing Human Space Flight Research Through Innovation and Collaboration}, booktitle = {Contribution to the NASA Online-Conference for Advancing Human Space Flight Research Through Innovation and Collaboration}, year = {2021}, language = {en} } @article{IbenthalKehmannBackhaus2021, author = {Ibenthal, E. and Kehmann, M. and Backhaus, C.}, title = {Effectiveness of personalized music systems to influence neuropsychiatric symptoms associated with dementia: a quasi-experimental study}, series = {EXPLORE: The Journal of Science \& Healing}, volume = {18}, journal = {EXPLORE: The Journal of Science \& Healing}, doi = {10.1016/j.explore.2021.03.004}, pages = {319 -- 326}, year = {2021}, language = {en} }