Streamlining Regulatory Compliance for Medical Devices Engineering

Meeting regulatory compliance is becoming increasingly challenging and costly for medical device development teams. Meeting regulations is typically addressed by adopting recommended industry practices such as ISO 13485, ISO 14971, IEC 62304, and FDA design control. The intent of the practices is to perform robust engineering to assure the safe operation of such devices. To fulfil that all the industry recommendations expect common practices such as requirements driven development, traceability, configuration control, audit trail, risk assessment, and review procedures. All these need to be documented as evidence of their performance.

Fulfilling all those activities can be costly and significantly slow down engineering if not done effectively. We present a digital engineering lifecycle solution that streamlines the performance of all the necessary recommendations as part of the integral engineering activities. This means that engineers continue to focus on engineering tasks and innovation, and not on maintaining compliance documentation.

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 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 is central review and change management, and especially the central reporting system. It automates all the necessary compliance evidence that shows traceability to requirements, coverage of testing, review, configuration and change control activities.

In addition it also fosters agile enactment to actually increase the speed of innovation with agile planning and tracking system alongside the robustness regulatory activities. It also enables reuse of engineering artifacts to further accelerate the effectiveness of engineering.

We will conclude by providing a Med customer case that 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.

Referenten: Peter Schedl, IBM Deutschland GmbH und Eran Gery, IBM Israel

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: Digitalisierung in der Medizintechnik

Zielgruppe: Projektleiter, Qualitätsmanager, Architekten, Softwareentwickler

Anspruch: Fortgeschrittene

Schlüsselwörter: Digital Engineering, Regulatory Compliance, agile development, Verification, Traceability, OSLC

Datum und Uhrzeit: 10. Mai 2022, 19:00 bis 19:45

Raum: Wien/Athen

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