Digital Engineering von Medizingeräten

We present an engineering lifecycle solution which enables speed of innovation, helps meeting medical device regulations across different geographies and assuring quality to avoid recalls effectively.

The core of the solution is an integrated engineering approach that enables creation of digital threads across engineering disciplines and engineering domains, starting from requirements, risk analysis, product design, cross discipline implementation to verification and validation at component, subsystem and device level. The integration approach is based on OSLC, an open architecture that is based on semantic web (W3C). Being open, the solution also allows to integrate other applications, for example from electrical and mechanical disciplines. The integrated environment is the foundation for quality engineering assuring data consistency as well as integration of verification and validation activities with the requirements and design artifacts.

Another key capability that directly addresses key challenges of medical regulatory practices such ISO 13485, 14971 and IEC 62304 is a central review and change management, and especially the central reporting system. It leverages the cross-domain engineering data model to automate all the necessary evidence that shows traceability to requirements, coverage of testing, review, configuration and change control activities. It also enables to get continuous visibility to progression and quality trends directly from actual engineering activities which increases the trustworthiness of reported data vs. manual reporting and documentation.

To increase speed of innovation, the solution includes an agile planning and tracking system to foster agile product engineering. It allows digital collaboration across all engineers by enabling discussion threads and personal dashboards related to all engineering artifacts. In addition the solution enables reuse of engineering artifacts to rapidly design new product variants. We will present a customer example who leveraged the described capabilities.

 

Was lernen die Zuhörer in dem Vortrag:

Wir zeigen auf wie Digital Engineering hilft den Entwicklungsprozess zu beschleunigen und gleichzeitig die Produktqualität zu erhöhen.

 

Referent: Peter Schedel und Eran Gery, IBM Deutschland GmbH

Peter Schedl befasst sich seit mehr als 20 Jahren mit Themen im Bereich der Entwicklung von mechatronischen Systemen. Bereits frühzeitig lernte er den Mehrwert eines ganzheitlichen Vorgehens bei der Erstellung von System-, HW- & SW-Architekturen schätzen.

Im Rahmen von verschiedensten Projekten z.B. im Automobil, Bahn, Medizin und Luftfahrt Umfeld konnte er erst Erfahrungen mit der Einführung von methodischen Vorgehensweisen sammeln und später als Berater weitergeben.
Aktuell befasst er sich insbesondere mit den Herausforderungen, die die digitalen Transformation an Entwickler von Produkten und Services stellt, und wie diese mit Hilfe von künstlicher Intelligenz gemeistert werden können.

Eran Gery is a World-Wide solution lead for IBM Engineering Lifecycle Management (ELM). Eran leads the engineering practices and solution architectures for IBM ELM for regulatory industrial domains, With special focus on Medical Devices, Aerospace and Defense, and Automotive. Eran’s expertise includes Systems and Software Engineering practices, Model Based Engineering, Product Line Engineering, and Automation of regulatory practices. Eran has over 25 years of experience within the complex systems domain working on digital and tool practices with major customers worldwide in the abovementioned industries. Eran is also an active member of the SysML V2 specification team in the OMG and was part of the SysML and UML founding teams.

Key Facts

Themengebiet: Software Entwicklung und Architekturen

Anspruch: Fortgeschrittene

Schlüsselwörer: Digital Engineering, agile development, MBSE, Verification, Traceability, OSLC

Datum und Uhrzeit: 20. Oktober 2021, 16:30 bis 17:15

Raum: Paris

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