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A formal methods approach to medical device review

    https://ieeexplore.ieee.org/document/1620997/
    A formal methods approach to medical device review. Abstract: With software playing an increasingly important role in medical devices, regulatory agencies such as the US Food and Drug Administration need effective means for …

A Formal Methods Approach to Medical …

    https://www.researchgate.net/publication/2956521_A_Formal_Methods_Approach_to_Medical_Device_Review
    The authors propose device usage models as a basis for applying formal methods and static analysis …

A Formal Methods Approach to Medical Device Review

    https://dl.acm.org/doi/10.1109/MC.2006.113
    The research presented here applies formal methods-based te... As device software becomes more complex, regulators need rigorous evaluation tools and methods to …

A Formal Methods Approach to Medical Device Review

    https://www.researchgate.net/profile/Raoul-Jetley-3/publication/2956521_A_Formal_Methods_Approach_to_Medical_Device_Review/links/54377a220cf2dc341db4d803/A-Formal-Methods-Approach-to-Medical-Device-Review.pdf
    requirements and domain specifications rele-vant to the device being modeled. CDRHdefines the model using formal-methods-based specification techniques, …

A Formal Methods Approach to Medical Device Review

    https://www.computer.org/csdl/magazine/co/2006/04/r4061/13rRUwwslxn
    The research presented here applies formal methods-based techniques to this problem space. As device software becomes more complex, regulators need rigorous evaluation …

A formal methods approach to medical device review

    https://www.semanticscholar.org/paper/A-formal-methods-approach-to-medical-device-review-Jetley-Iyer/16e49e18ffe818845bdce52bf1f2490b9678edc9/figure/0
    Figure 1. Schematic showing how a usage model is used to enhance CDRH’s premarket review process.The scheme as depicted involves deriving a test-case suite from a …

A Formal Approach to Pre-Market Review for Medical …

    https://ieeexplore.ieee.org/abstract/document/4020075
    Abstract: In this paper we explore a method for carrying out pre-market analysis of software designs and implementations, based on formal-methods …

A Formal Methods-based verification …

    https://www.embedded.com/a-formal-methods-based-verification-approach-to-medical-device-software-analysis/
    This section discusses these methods and introduces the application of formal methods”based abstract interpretation to code verification. Code Review. The …

A Formal Methods-based verification approach to …

    https://www.researchgate.net/profile/Raoul-Jetley-4/publication/297797097_Formal_methods-based_verification_of_medical_device_software_analysis/links/5f801b17a6fdccfd7b51e60c/Formal-methods-based-verification-of-medical-device-software-analysis.pdf
    Medical devices address a continuum of diagnosis and treatment applications varying in complexity from digital thermometers, insulin pumps, pacemakers, and cardiac monitors …

A slicing-based approach to postmarket review. Criteria …

    https://www.researchgate.net/figure/A-slicing-based-approach-to-postmarket-review-Criteria-for-slicing-are-refined_fig2_2956521
    A Formal Methods Approach to Medical Device Review Article Full-text available May 2006 Raoul Jetley S. Purushothaman Iyer Paul L Jones With software playing an …



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