Add an event2nd Annual Software Design for Medical Devices Europe
Ensuring Compliance to Evolving Regulations and Standards whilst Incorporating Quality & Usability into Agile Design
15 speakers
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Universität Münster @wwu_muenster Uvo Hölscher, Professor, Medical Technology and Ergonomics
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FDA Medical Devices @fdadeviceinfo Molly Story, Human Factors and Accessible Medical Technology Specialist, Office of Device Evaluation, Center for Devices and Rad
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Werner Kexel Managing Director, Eurocat
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Straumann @straumann Andreas Petermann, Director Regulatory Affairs
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Thorsten Creter Associate Project Engineer, Underwriters Laboratories
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Flextronics @flex_tronics Marco Rigamonti, Manager, Software Engineering Department
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TÜV SÜD AG @tuev_sued Markus Wagner, Lead Auditor, Quality Management Systems
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Novo Nordisk GA&PP @novonordisk_ga Peter Bøge, Specialist
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Siemens Healthcare @SiemensHealth Markus Nagel, Director of Quality Management
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Ed Israelski Director Human Factors, Abbott
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Given Imaging ProfEd @givenimagingedu Iddo Ambor, Director, Software and Platforms
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Dräger Medical Sonja Lederhilger, Usability Engineer
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Axon Lawyers @axonlawyers Erik Vollebregt, Partner
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GE Healthcare @GEHealthcare Paivi Roiha, Regulatory Affairs Leaders
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Medtronic Diabetes @mdt_diabetes Patty Krantz, CRDM Standards Advisor
15 sessions
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REGULATOR: Comprehending and Complying to the New EU Guideline on the Qualification and Classification of Standalone Software in
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Case Study: Understanding the Changes within IEC 60601 3rd Edition and Developing an Efficient Compliance and Implementation Str
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The Shifting Landscape of Software Compliance
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INTERACTIVE SESSION: Panel Discussion: Standards for Software in Medical Devices: Updates, Compliance and Differences in Interpr
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INTERACTIVE SESSION: Insight Session: Overview of International Standards Activities Related to Medical Software Development
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CASE STUDY: Agile Methodology in a Complex Software Design and Integration for Improved Device Functionality
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Case Study: Agile Scrum Methodology Implementation within a Generation-Based Software Development Life Cycle
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Legal and Regulatory Aspects of Medical Devices Software: Do's, Don'ts and Developments
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CASE STUDY: Implementation of Risk Management for the Whole Life Cycle of Medical Devices
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Case Study: An Outside Perspective – Developing Efficient Usability Processes at Novo Nordisk
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Case Study: From Concept to Completion: Developing Effective Usability Processes Across the Whole Product Lifecycle
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Risk Management: Using Human Factors Engineering to Manage the Risk of Use Error in Medical Software
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REGULATOR: Afternoon Keynote: The FDA Perspective on Human Factors in Medical Device Software Development
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INTERACTIVE SESSION: Panel Discussion: Usability in Medical Device Design: Can we Improve Product Quality while Optimising Devel
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Designing Usable and Safe Medical Devices
