Developing IEC 62304–Compliant Embedded Software for 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

  • 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

Dr. Visa Suomi is the Medical Devices Industry Manager at MathWorks. He has over 10 years of international experience in the life sciences and healthcare sector, with an interdisciplinary background from the medical technology industry, academia, and clinical research. He holds a doctoral degree (DPhil in Healthcare Innovation) from the University of Oxford, UK, with the focus on translating academic and clinical research into commercial applications.

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