---
res:
  bibo_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.@eng
  bibo_authorlist:
  - foaf_Person:
      foaf_givenName: Iris
      foaf_name: Gräßler, Iris
      foaf_surname: Gräßler
      foaf_workInfoHomepage: http://www.librecat.org/personId=47565
    orcid: 0000-0001-5765-971X
  - foaf_Person:
      foaf_givenName: Jan Niklas
      foaf_name: Pfeifer, Jan Niklas
      foaf_surname: Pfeifer
      foaf_workInfoHomepage: http://www.librecat.org/personId=62841
  - foaf_Person:
      foaf_givenName: Denis
      foaf_name: Trost, Denis
      foaf_surname: Trost
  bibo_doi: https://doi.org/10.1002/iis2.70264
  bibo_issue: '1'
  bibo_volume: 36
  dct_date: 2026^xs_gYear
  dct_isPartOf:
  - http://id.crossref.org/issn/2334-5837
  dct_language: eng
  dct_publisher: Wiley@
  dct_subject:
  - Regulations
  - Product Lifecycle Management
  - Requirements Engineering
  - Model-Based Systems Engineering
  - medical technology
  dct_title: RegPLM – A method for the application of regulation-centered PLM platforms@
...