---
_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: <i>INCOSE International Symposium</i>. Vol 36. Wiley; 2026:1641-1655.
    doi:<a href="https://doi.org/10.1002/iis2.70264">https://doi.org/10.1002/iis2.70264</a>'
  apa: Gräßler, I., Pfeifer, J. N., &#38; Trost, D. (2026). RegPLM – A method for
    the application of regulation-centered PLM platforms. <i>INCOSE International
    Symposium</i>, <i>36</i>(1), 1641–1655. <a href="https://doi.org/10.1002/iis2.70264">https://doi.org/10.1002/iis2.70264</a>
  bibtex: '@inproceedings{Gräßler_Pfeifer_Trost_2026, place={Yokohama}, title={RegPLM
    – A method for the application of regulation-centered PLM platforms}, volume={36},
    DOI={<a href="https://doi.org/10.1002/iis2.70264">https://doi.org/10.1002/iis2.70264</a>},
    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 <i>INCOSE International
    Symposium</i>, 36:1641–55. Yokohama: Wiley, 2026. <a href="https://doi.org/10.1002/iis2.70264">https://doi.org/10.1002/iis2.70264</a>.'
  ieee: 'I. Gräßler, J. N. Pfeifer, and D. Trost, “RegPLM – A method for the application
    of regulation-centered PLM platforms,” in <i>INCOSE International Symposium</i>,
    Yokohma, Japan, 2026, vol. 36, no. 1, pp. 1641–1655, doi: <a href="https://doi.org/10.1002/iis2.70264">https://doi.org/10.1002/iis2.70264</a>.'
  mla: Gräßler, Iris, et al. “RegPLM – A Method for the Application of Regulation-Centered
    PLM Platforms.” <i>INCOSE International Symposium</i>, vol. 36, no. 1, Wiley,
    2026, pp. 1641–55, doi:<a href="https://doi.org/10.1002/iis2.70264">https://doi.org/10.1002/iis2.70264</a>.
  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'
...