Industry: Medical

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  • Reducing the Risk of the Software Supply Chain in Medical Devices

    Reducing the Risk of the Software Supply Chain in Medical Devices

        INTRODUCTION: Medical devices rely on third-party and in-house existing software as needed, to meet functionality, cost, and time-to-market concerns. Although software of unknown pedigree...

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  • New Approaches Needed for Medical Device Software Development

    New Approaches Needed for Medical Device Software Development

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  • Designing Security into Medical Device Software

    Designing Security into Medical Device Software

     

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  • Designing Security into Medical Device Software

    Designing Security into Medical Device Software

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  • The Role of Static Analysis in Management of Cybersecurity in Medical Devices

    The Role of Static Analysis in Management of Cybersecurity in Medical Devices

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  • The Role of Static Analysis in Management of Cybersecurity in Medical Devices

    The Role of Static Analysis in Management of Cybersecurity in Medical Devices

    INTRODUCTION: The FDA, recognizing the need for more robust security in medical devices, issued its guidance on managing cybersecurity in 2014. The growth of wireless, networked, and...

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  • FDA Post-Market Static Analysis of Medical Device Software

    INTRODUCTION: Software in medical devices ideally provides better functionality, usability and safety. However, software is complex and prone to errors. The Federal Drug Administration (FDA)...

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  • Static Analysis and IEC 62304

    INTRODUCTION: The IEC/ISO 62304 standard defines a risk and quality driven software development process for medical device software. The standard emerged from a recognition that software plays a...

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  • FDA's Use of CodeSonar® Detailed in Embedded Systems Design

    Embedded Systems Design today published an article co-authored by Raoul Jetley of the FDA and GrammaTech's Paul Anderson, titled "Using static analysis to evaluate software in...

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