@inproceedings{67174,
  abstract     = {{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       = {{Gräßler, Iris and Pfeifer, Jan Niklas and Trost, Denis}},
  booktitle    = {{INCOSE International Symposium}},
  issn         = {{2334-5837}},
  keywords     = {{Regulations, Product Lifecycle Management, Requirements Engineering, Model-Based Systems Engineering, medical technology}},
  location     = {{Yokohma, Japan}},
  number       = {{1}},
  pages        = {{1641 -- 1655}},
  publisher    = {{Wiley}},
  title        = {{{RegPLM – A method for the application of regulation-centered PLM platforms}}},
  doi          = {{https://doi.org/10.1002/iis2.70264}},
  volume       = {{36}},
  year         = {{2026}},
}

@article{32174,
  abstract     = {{<jats:title>Abstract</jats:title><jats:p>Increasing 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.</jats:p>}},
  author       = {{Gräßler, Iris and Thiele, Henrik and Grewe, Benedikt and Hieb, Michael}},
  issn         = {{2732-527X}},
  journal      = {{Proceedings of the Design Society}},
  keywords     = {{systems engineering (SE), project management, model-based systems engineering (MBSE)}},
  location     = {{Dubrovnik}},
  pages        = {{1875--1884}},
  publisher    = {{Cambridge University Press (CUP)}},
  title        = {{{Responsibility Assignment in Systems Engineering}}},
  doi          = {{10.1017/pds.2022.190}},
  volume       = {{2}},
  year         = {{2022}},
}

@inproceedings{24280,
  abstract     = {{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       = {{Gräßler, Iris and Wiechel, Dominik}},
  booktitle    = {{DS 111: Proceedings of the 32nd Symposium Design for X}},
  editor       = {{Krause, Dieter and Paetzold, Kristin and Wartzack, Sandro}},
  keywords     = {{Engineering Change Management, Impact Analysis, Engineering  Changes, Model-based Systems Engineering, Product Developmen}},
  location     = {{Tutzing}},
  title        = {{{Systematische Bewertung von Auswirkungsanalysen des Engineering Change Managements}}},
  doi          = {{10.35199/dfx2021.12}},
  year         = {{2021}},
}