---
_id: '67174'
abstract:
- lang: eng
text: Approval of products in safety-sensitive areas, such as medical technology,
requires considerable effort. Companies must comply with numerous regulations
for such product approvals. This results in requirements for processes, methods,
tools and organizations throughout the product life cycle. A proven approach to
handling regulatory requirements is the application of product lifecycle management
(PLM) platforms. Applying PLM platforms (e.g. Teamcenter, 3DExperience) poses
challenges in designing compliant processes as well as adapting methods and tools.
For example, in medical technology, ISO 13485 specifies an industry-specific product
engineering process. The exemplary adaptations of requirements engineering methods
and related support – e.g. MBSE including Requirements Diagrams – are not intuitively
apparent. Existing literature primarily regards these regulation-related challenges
as boundary conditions, offering only vague operational solutions. Companies struggle
to align PLM processes with regulatory requirements, yet few methods exist to
support this integration. In this paper, a method is proposed that supports the
application of regulation-centered PLM platforms and reduces effort in product
approvals. The method is developed by applying a five-step approach. Existing
literature on process models for applying PLM platforms is identified (1). The
identified approaches are then analyzed to determine whether and to what extent
they consider regulations in applying PLM platforms (2). Based on identified partial
solutions from literature and findings from industry workshops, a new method is
developed (3). The method comprises strategic level, process level, data level,
pilot level, and operation level. Validation is conducted within a German medical
technology company, containing proof of applicability determined through a pilot
project (4) and proof of concept achieved through interviews (5). The method is
applied to regulation-centered PLM for the use case ‘requirements engineering’.
The concept is confirmed by experts in terms of applicability and transferability.
The method supports engineers in applying regulation-centered PLM platforms, leading
to reduced effort.
author:
- first_name: Iris
full_name: Gräßler, Iris
id: '47565'
last_name: Gräßler
orcid: 0000-0001-5765-971X
- first_name: Jan Niklas
full_name: Pfeifer, Jan Niklas
id: '62841'
last_name: Pfeifer
- first_name: Denis
full_name: Trost, Denis
last_name: Trost
citation:
ama: 'Gräßler I, Pfeifer JN, Trost D. RegPLM – A method for the application of regulation-centered
PLM platforms. In: INCOSE International Symposium. Vol 36. Wiley; 2026:1641-1655.
doi:https://doi.org/10.1002/iis2.70264'
apa: Gräßler, I., Pfeifer, J. N., & Trost, D. (2026). RegPLM – A method for
the application of regulation-centered PLM platforms. INCOSE International
Symposium, 36(1), 1641–1655. https://doi.org/10.1002/iis2.70264
bibtex: '@inproceedings{Gräßler_Pfeifer_Trost_2026, place={Yokohama}, title={RegPLM
– A method for the application of regulation-centered PLM platforms}, volume={36},
DOI={https://doi.org/10.1002/iis2.70264},
number={1}, booktitle={INCOSE International Symposium}, publisher={Wiley}, author={Gräßler,
Iris and Pfeifer, Jan Niklas and Trost, Denis}, year={2026}, pages={1641–1655}
}'
chicago: 'Gräßler, Iris, Jan Niklas Pfeifer, and Denis Trost. “RegPLM – A Method
for the Application of Regulation-Centered PLM Platforms.” In INCOSE International
Symposium, 36:1641–55. Yokohama: Wiley, 2026. https://doi.org/10.1002/iis2.70264.'
ieee: 'I. Gräßler, J. N. Pfeifer, and D. Trost, “RegPLM – A method for the application
of regulation-centered PLM platforms,” in INCOSE International Symposium,
Yokohma, Japan, 2026, vol. 36, no. 1, pp. 1641–1655, doi: https://doi.org/10.1002/iis2.70264.'
mla: Gräßler, Iris, et al. “RegPLM – A Method for the Application of Regulation-Centered
PLM Platforms.” INCOSE International Symposium, vol. 36, no. 1, Wiley,
2026, pp. 1641–55, doi:https://doi.org/10.1002/iis2.70264.
short: 'I. Gräßler, J.N. Pfeifer, D. Trost, in: INCOSE International Symposium,
Wiley, Yokohama, 2026, pp. 1641–1655.'
conference:
end_date: 2026-06-18
location: Yokohma, Japan
name: 36th Annual INCOSE International Symposium
start_date: 2026-06-13
date_created: 2026-09-18T08:54:01Z
date_updated: 2026-09-18T08:56:11Z
doi: https://doi.org/10.1002/iis2.70264
intvolume: ' 36'
issue: '1'
keyword:
- Regulations
- Product Lifecycle Management
- Requirements Engineering
- Model-Based Systems Engineering
- medical technology
language:
- iso: eng
page: 1641 - 1655
place: Yokohama
publication: INCOSE International Symposium
publication_identifier:
issn:
- 2334-5837
publication_status: published
publisher: Wiley
quality_controlled: '1'
status: public
title: RegPLM – A method for the application of regulation-centered PLM platforms
type: conference
user_id: '62841'
volume: 36
year: '2026'
...
---
_id: '32174'
abstract:
- lang: eng
text: AbstractIncreasing system complexity can
be controlled by using systems engineering processes. INCOSE defines processes
with inputs and outputs (artifacts) for this purpose. Specific SE roles are used
to organize the tasks of the processes within the company. In this work, the responsibilities
for artifacts are evaluated by means of the RACI scheme and examined by a cluster
analysis and discussed for a SE transformation project with a German automotive
OEM. As a result of the study, the optimal composition for systems engineering
teams is identified and the systems engineering roles are prioritized.
article_type: original
author:
- first_name: Iris
full_name: Gräßler, Iris
id: '47565'
last_name: Gräßler
orcid: 0000-0001-5765-971X
- first_name: Henrik
full_name: Thiele, Henrik
id: '33419'
last_name: Thiele
- first_name: Benedikt
full_name: Grewe, Benedikt
id: '52359'
last_name: Grewe
- first_name: Michael
full_name: Hieb, Michael
id: '72252'
last_name: Hieb
citation:
ama: Gräßler I, Thiele H, Grewe B, Hieb M. Responsibility Assignment in Systems
Engineering. Proceedings of the Design Society. 2022;2:1875-1884. doi:10.1017/pds.2022.190
apa: Gräßler, I., Thiele, H., Grewe, B., & Hieb, M. (2022). Responsibility Assignment
in Systems Engineering. Proceedings of the Design Society, 2, 1875–1884.
https://doi.org/10.1017/pds.2022.190
bibtex: '@article{Gräßler_Thiele_Grewe_Hieb_2022, title={Responsibility Assignment
in Systems Engineering}, volume={2}, DOI={10.1017/pds.2022.190},
journal={Proceedings of the Design Society}, publisher={Cambridge University Press
(CUP)}, author={Gräßler, Iris and Thiele, Henrik and Grewe, Benedikt and Hieb,
Michael}, year={2022}, pages={1875–1884} }'
chicago: 'Gräßler, Iris, Henrik Thiele, Benedikt Grewe, and Michael Hieb. “Responsibility
Assignment in Systems Engineering.” Proceedings of the Design Society 2
(2022): 1875–84. https://doi.org/10.1017/pds.2022.190.'
ieee: 'I. Gräßler, H. Thiele, B. Grewe, and M. Hieb, “Responsibility Assignment
in Systems Engineering,” Proceedings of the Design Society, vol. 2, pp.
1875–1884, 2022, doi: 10.1017/pds.2022.190.'
mla: Gräßler, Iris, et al. “Responsibility Assignment in Systems Engineering.” Proceedings
of the Design Society, vol. 2, Cambridge University Press (CUP), 2022, pp.
1875–84, doi:10.1017/pds.2022.190.
short: I. Gräßler, H. Thiele, B. Grewe, M. Hieb, Proceedings of the Design Society
2 (2022) 1875–1884.
conference:
end_date: 2022-05-26
location: Dubrovnik
name: 17th International DESIGN Conference
start_date: 2022-05-23
date_created: 2022-06-27T07:51:41Z
date_updated: 2023-01-24T08:41:31Z
ddc:
- '620'
department:
- _id: '152'
doi: 10.1017/pds.2022.190
file:
- access_level: closed
content_type: application/pdf
creator: hthiele
date_created: 2022-06-27T07:56:35Z
date_updated: 2022-06-27T07:56:35Z
file_id: '32175'
file_name: responsibility-assignment-in-systems-engineering.pdf
file_size: 787640
relation: main_file
success: 1
file_date_updated: 2022-06-27T07:56:35Z
has_accepted_license: '1'
intvolume: ' 2'
keyword:
- systems engineering (SE)
- project management
- model-based systems engineering (MBSE)
language:
- iso: eng
main_file_link:
- open_access: '1'
url: https://www.cambridge.org/core/journals/proceedings-of-the-design-society/article/responsibility-assignment-in-systems-engineering/07269DA1B1160C17AF0E0BE6035FD1A2
oa: '1'
page: 1875-1884
publication: Proceedings of the Design Society
publication_identifier:
issn:
- 2732-527X
publication_status: published
publisher: Cambridge University Press (CUP)
quality_controlled: '1'
status: public
title: Responsibility Assignment in Systems Engineering
type: journal_article
user_id: '72252'
volume: 2
year: '2022'
...
---
_id: '24280'
abstract:
- lang: eng
text: 'Challenges in decisions on technical changes are the lack of knowledge about
the expected impact and change propagation. Currently, no literature study contains
a systematic differentiation and evaluation of existing approaches, which is a
prerequisite for practitioners to select a suitable approach. This research aims
at defining differentiation criteria as well as generally applicable requirements
for evaluation. A four-step approach is used: systematic literature review on
approaches for impact analysis of engineering changes (1), categorization and
prioritization of approaches based on reoccuring elements (2), derivation of context
specific requirements for evaluation (3), and evaluation of approaches (4). The
result indicates existing potential of object-oriented modeling approaches.'
author:
- first_name: Iris
full_name: Gräßler, Iris
id: '47565'
last_name: Gräßler
orcid: 0000-0001-5765-971X
- first_name: Dominik
full_name: Wiechel, Dominik
id: '67161'
last_name: Wiechel
citation:
ama: 'Gräßler I, Wiechel D. Systematische Bewertung von Auswirkungsanalysen des
Engineering Change Managements. In: Krause D, Paetzold K, Wartzack S, eds. DS
111: Proceedings of the 32nd Symposium Design for X. ; 2021. doi:10.35199/dfx2021.12'
apa: 'Gräßler, I., & Wiechel, D. (2021). Systematische Bewertung von Auswirkungsanalysen
des Engineering Change Managements. In D. Krause, K. Paetzold, & S. Wartzack
(Eds.), DS 111: Proceedings of the 32nd Symposium Design for X. https://doi.org/10.35199/dfx2021.12'
bibtex: '@inproceedings{Gräßler_Wiechel_2021, title={Systematische Bewertung von
Auswirkungsanalysen des Engineering Change Managements}, DOI={10.35199/dfx2021.12},
booktitle={DS 111: Proceedings of the 32nd Symposium Design for X}, author={Gräßler,
Iris and Wiechel, Dominik}, editor={Krause, Dieter and Paetzold, Kristin and Wartzack,
Sandro}, year={2021} }'
chicago: 'Gräßler, Iris, and Dominik Wiechel. “Systematische Bewertung von Auswirkungsanalysen
Des Engineering Change Managements.” In DS 111: Proceedings of the 32nd Symposium
Design for X, edited by Dieter Krause, Kristin Paetzold, and Sandro Wartzack,
2021. https://doi.org/10.35199/dfx2021.12.'
ieee: 'I. Gräßler and D. Wiechel, “Systematische Bewertung von Auswirkungsanalysen
des Engineering Change Managements,” in DS 111: Proceedings of the 32nd Symposium
Design for X, Tutzing, 2021, doi: 10.35199/dfx2021.12.'
mla: 'Gräßler, Iris, and Dominik Wiechel. “Systematische Bewertung von Auswirkungsanalysen
Des Engineering Change Managements.” DS 111: Proceedings of the 32nd Symposium
Design for X, edited by Dieter Krause et al., 2021, doi:10.35199/dfx2021.12.'
short: 'I. Gräßler, D. Wiechel, in: D. Krause, K. Paetzold, S. Wartzack (Eds.),
DS 111: Proceedings of the 32nd Symposium Design for X, 2021.'
conference:
end_date: 28-09-2021
location: Tutzing
name: Symposium Design for X (DFX2021)
start_date: 27-09-2021
date_created: 2021-09-13T14:45:10Z
date_updated: 2023-05-09T18:22:30Z
department:
- _id: '152'
doi: 10.35199/dfx2021.12
editor:
- first_name: Dieter
full_name: Krause, Dieter
last_name: Krause
- first_name: Kristin
full_name: Paetzold, Kristin
last_name: Paetzold
- first_name: Sandro
full_name: Wartzack, Sandro
last_name: Wartzack
keyword:
- Engineering Change Management
- Impact Analysis
- Engineering Changes
- Model-based Systems Engineering
- Product Developmen
language:
- iso: eng
publication: 'DS 111: Proceedings of the 32nd Symposium Design for X'
publication_status: published
quality_controlled: '1'
status: public
title: Systematische Bewertung von Auswirkungsanalysen des Engineering Change Managements
type: conference
user_id: '67161'
year: '2021'
...