MATLAB and Simulink Seminars

Verification and validation of safety-critical medical devices


Overview

Whether you are an embedded software developer or an engineer designing a medical device, software quality is critical for patient safety.

Model-Based Design incorporates verification and validation into the software development workflow. As a result, the software is comprehensively tested and verified before you integrate it into a medical device. In addition, parts of the documentation required by IEC 62304 are automatically generated for regulatory compliance. 

But how does Model-Based Design work in practice? And how do you get started? Join this webinar to learn the best practices for improving software quality while reducing development time and costs.

Highlights

  • Practical demonstration of the workflow using an infusion pump model
  • Requirements management and system architecture design
  • Automated unit and system level testing with test report generation
  • IEC 62304 supported workflow for FDA/MDR regulatory compliance

Who Should Attend

Embedded software developers, system engineers and managers in charge of V&V processes and regulatory compliance for medical device design.

About the Presenter

Mauro Fusco is an application engineer at MathWorks in Eindhoven. He specializes in supporting customers in aerospace, automotive and machinery industries for the establishment of Design Automation workflows. Modelling, simulation, testing and implementation through automatic code generation whilst conforming to international standards are key aspects of his work. He is currently working on transferring this knowledge into the medical Industry for safety critical applications.

Before joining MathWorks, he worked at the Dutch Organization for Applied Research, TNO, focusing on the domain of Controls for Cooperative and Autonomous Driving. Mauro has a Masters in Automation Engineering from the University of Naples Federico II, during which time he conducted research at Eindhoven University of Technology. His technical expertise lies in the areas of Control Theory, Nonlinear and Network Control and their implementation.

Christian Merkl is an application engineer at MathWorks in Munich. His background is in aerospace engineering with more than ten years of professional experience in industry and research. At MathWorks he focuses on Model-Based Design and workflows for safety critical applications.

He started his carrier in industry, working on flight mechanics studies and the development of an electrical UAV. Parallel he was a researcher at Technische University Munich, and specialized on applications of online system identification algorithms for flight control design. Christian received his PhD in aeronautical engineering from the TU Munich in 2019.

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