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@PHDTHESIS{CastaoReyes:818969,
author = {Castaño Reyes, Carmen Elizabeth},
othercontributors = {Schmitt, Robert H. and del Carmen Valderrama Bahmóndez,
Elba},
title = {{A} model-based approach to comprehensive risk management
for medical devices; 1st edition},
school = {RWTH Aachen University},
type = {Dissertation},
address = {Panama},
publisher = {Carmen E. Castaño R.},
reportid = {RWTH-2021-04766},
isbn = {978-9962-13-825-9},
pages = {1 Online-Ressource : Illustrationen},
year = {2021},
note = {Druckausgabe: 2021. - Auch veröffentlicht auf dem
Publikationsserver der RWTH Aachen University; Dissertation,
RWTH Aachen University, 2021},
abstract = {Medical devices are becoming more complex than ever, as do
the networks they pertain to. The current trends in MedTech
manufacturing complicate the work of a systematical and
comprehensive RM process. At present, manufacturers
implement many different, but exclusively document-based RM
approaches. The work described in this thesis focuses on
conceiving and validating a model-based risk management
system that enables RM operators to overcome the endemic
deficits of the document-based approaches. This shall be
achieved by the formalization of RM steps, the role-based
separation of procedures in computation and human action and
by providing an RM system that enables an iterative RM
process during the entire product lifecycle for all
stakeholders. The research approach adopted mainly comprises
an extensive study of relevant literature, reasoning and an
implementation of applied research, carried out in a case
study. A systematical and comprehensive RM for medical
devices can be accomplished with a MBR concept. The
iterative system design separates the operational and
computational procedures in the MBR Core from the actions of
the experts and stakeholders. A universal API processes all
changes to and all documents generated from the MBR core.
The sequential use of human expertise and computational
rigor allows for the integration of document-based RM
methods and techniques that are broadly accepted in the
industry. A main factor for comprehensive RM results is the
computerization of the identification of critical
characteristics. The elements of the physical product are
tagged with approved industry classifications. A novelty in
product modeling is the utilization of an own block class
for interactions instead of relational elements; it has
proven to be functional and valuable in implementation. The
software implementation of the system is shown on a
demonstrator level. The validation of MBR in a case study
applying two RM methods on two similar complex medical
device systems, advanced prototypes of automated stem cell
platforms, has shown the potential to drastically reduce the
deficits endemic to document-based approaches. The
augmentation of established RM techniques with legacy
information can improve identification of critical
characteristics. However, the case study also showed that
the disposition of the panelists is key to the success of
the concept. While proficient users of tools in MBSE
explored the full potential in the utility tests, panelists
with a basic to intermediate knowledge of MBSE, showed
strong reservations against accepting “advise” from the
augmented graphical model. In total, the model-based RM
approach can be a significant contribution to the
improvement of RM processes for complex medical devices and,
in general, to the dissemination of risk-based thinking
throughout all lifecycle stages, provided that all
stakeholders engage in an openminded and interdisciplinary
process.},
cin = {417510 / 417200},
ddc = {620},
cid = {$I:(DE-82)417510_20140620$ / $I:(DE-82)417200_20140620$},
typ = {PUB:(DE-HGF)11 / PUB:(DE-HGF)3},
doi = {10.18154/RWTH-2021-04766},
url = {https://publications.rwth-aachen.de/record/818969},
}
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