Integration of systems design and risk management through model‐based systems development

Uludag, Yildiz; Evin, Ersin; Gürbüz, Nazan Gözay

doi:10.1002/sys.21643

Cited by 4 publications

(2 citation statements)

References 40 publications

(76 reference statements)

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“…Certain efforts show the benefits of MBSE-based approaches [15] [16] [17] but, in practice, support for MBSE is not well elaborated. In the medical domain, while ISO 14971 is well-structured in its scope, its integration with the MD development process is left to individual manufacturers.…”

Section: Introductionmentioning

confidence: 99%

“…In [16], authors show how to use SysML (System Modeling Language) activity models to link the steps of ISO 14971 to the system development technical processes of ISO 15288. [17] describes RM SysML profile for the IBM Rational Rhapsody software suite that includes interconnected elements of the safety analysis, control measure and evaluation model in accordance with medical standards. However, there is no clear indication of how the classical safety assessment methods implemented in the framework refer to the risk analysis flow described in ISO 14971.…”

Section: Introductionmentioning

confidence: 99%

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Model-Based ISO 14971 Risk Management of EEG-Based Medical Devices

Yakymets,

Zanetti,

Ionescu

et al. 2023

2023 45th Annual International Conference of the IEEE Engineering in Medicine &Amp; Biology Society (EMBC)

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Risk management (RM) is a key component of the development of modern medical devices (MD) to achieve acceptable functional safety and pass the regulatory process. The emerging availability of various techniques, languages, and tools that use model-based system engineering (MBSE) promises to facilitate the development and analysis of complex MD. In this paper, we show how to integrate RM principles and activities recommended in ISO 14971 medical standard into an MBSE-driven MD development process. We propose a method and framework capable of modeling essential RM concepts and performing RM and safety analysis in the early stages of the MD development life cycle. The framework extends OMG RAAML (Object Management Group Risk Analysis and Assessment Modeling Language) to the medical domain according to ISO 14971. We illustrate our approach using a case study of the e-Glass system developed for real-time EEG-based subject monitoring with the intended use of stress monitoring.Clinical Relevance-This facilitates the MD certification process by semi-automation of RM based on ISO 14971 and obtaining safe MD by design.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Model-Based ISO 14971 Risk Management of EEG-Based Medical Devices

Yakymets,

Zanetti,

Ionescu

et al. 2023

2023 45th Annual International Conference of the IEEE Engineering in Medicine &Amp; Biology Society (EMBC)

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Model‐based systems engineering and safety assessment: A workflow for mechatronic systems design

Bouhali,

Pasquariello,

Mhenni

et al. 2024

Systems Engineering

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Mechatronic systems become ever more complex because of their increasing number of interconnected safety critical components and sophistication. MBSE (Model‐based Systems Engineering) and MBSA (Model‐Based Safety Assessment) are the most commonly adopted approaches to deal with the design and safety analysis of mechatronic systems. Unfortunately, both approaches are normally adopted separately, especially in the earlier phases of system design, thus leading to a lack of communication between system engineers and the safety team. This work aims to fill that gap at a high level, that is, through process interaction. This paper proposes an enhanced V‐model for the design of safety‐critical mechatronic systems. It relates a system development process with specific safety assessment methods. Specifically, the proposed workflow details exchange flows between the RFLP (Requirements, Functional, Logical, Physical) method, the FHA (Functional Hazard Analysis), the FMEA (Failure Mode and Effects Analysis), the MBSA and simulation, and the FTA (Fault Tree Analysis). These analyses are complemented with multiphysics modeling and simulation to observe system behavior in functional and failure scenarios, with the aim of requirements verification. The design workflow has been applied to a winged Unmanned Aerial Vehicle to apply the parallel process and the necessary interaction of MBSE and MBSA approaches. The information flows between the individual activities proved effective for designing a safe system before the verification phase. The main benefit of the proposed workflow is providing both the design and safety team with some interaction points, thus avoiding a lack of safety‐critical analysis in the early phases of system design.

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Model-Based Functional Hazard Analysis for Safety Requirements of Complex Systems

Hu,

Jiao,

2023

2023 14th International Conference on Reliability, Maintainability and Safety (ICRMS)

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Integration of systems design and risk management through model‐based systems development

Cited by 4 publications

References 40 publications

Model-Based ISO 14971 Risk Management of EEG-Based Medical Devices

Model-Based ISO 14971 Risk Management of EEG-Based Medical Devices

Model‐based systems engineering and safety assessment: A workflow for mechatronic systems design

Model-Based Functional Hazard Analysis for Safety Requirements of Complex Systems

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