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  9 Ways to Use AI in Medical Device Development

  9 ways to use AI in medical device development from our experts include Connected Medical Devices, QA/RA, Developing (real time) Simulations, Expedite Design Process, Analysis and Research, Supplier Evaluations, Project Reviews, Brainstorming, and Administrative Help (Faster than Google).   

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  Six Project Manager Skills for Success in the Medical Device Industry

  A Project Manager navigating this complex medical device development landscape requires the ability to marry traditional Project Management Skills with the specificity of medical device industry practices that focus on patient outcomes and regulatory requirements. This article includes 5 skills that expert project manager, Shalaka Maind, deems crucial to medical device development success.

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  9 Biggest Productivity Drains and Their Solutions

  Can’t get your medical device development work done on time? We crowdsourced this dilemma to our employees, and they shared their biggest productivity drains and solutions. Spoiler alert: there were nine drains and five of them share the same solution.

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  Using CM&S to Improve Medical Device Development

  Computational modelling and simulation (CM&S) has been used for decades as an assistive tool for medical device design and development. Real-world examples of gathering evidence for submission to regulatory bodies, investigating fluid dynamics, structural, thermal, electro-magnetic, fluid-structure interactions, and other multiphysics problems.

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  Medical Device Vibration Analysis and Testing Reduce Risk

  The impact of vibration on medical devices can be understood through a combination of vibration analysis and testing. This article reviews medical devices most susceptible to vibration, provides basic theory and methods of vibration analysis, and summarizes the benefits of using modal analysis when developing medical devices.

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  Heart valve simulation shifts the treatment paradigm

  Simulation technologies are revolutionizing the field of heart valve repair and replacement, offering unprecedented insights and capabilities. Enhancing our understanding of valve mechanics, improving device design, optimizing surgical techniques, and enabling personalized treatments, simulations are paving the way for better cardiovascular care and patient outcomes. This article explores the transformative role of heart valve computational simulation in understanding, and treating heart valve diseases.

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  Starting Medical Device Projects on the Right Foot

  Four areas that can make or break a new medical device development project from the start. Experts identify actions and offer advice that helps ensure new medical device projects start on the right foot.

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  FDA Guidance on Computational Modeling and Simulation in Medical Device Submissions

  Summary of nine-step process for developing and assessing the credibility of CM&S for regulatory submissions in the FDA Guidance Document “Assessing the Credibility of Computational Modeling and Simulation (CM&S) in Medical Device Submissions (17th November 2023)”.

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  14 Ways to Increase Medical Device Speed to Market

  Speed to market is a crucial part of medical device success. Experts draw upon their experience with hundreds of medical device products for proven tips and recommendations that increase medical device speed to market without sacrificing safety or quality.

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