RegPLM – A method for the application of regulation-centered PLM platforms

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.