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Medical Devices Solutions Presentation

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6 Multidisciplinary Medical Device Total Product Lifecycle Bring safe and effective devices to the market while reducing time and costs to achieve regulatory approval. / Design Invention & Prototyping Ideate, design and optimize devices for safety and performance Perform predicate analysis to support next generation designs / Clinical Pre-Clinical Trial Simulate the pre-clinical test environment to reduce/refine animal testing Develop virtual patients based on computational models that predict clinical end-points Clinical Trial / Regulatory Affairs Regulatory Review Follow VVUQ best practices to develop regulatory-grade models Automatically generate computational model reports formatted to meet FDA submission requirements / Quality Assurance Quality Assurance Swiftly resolve CAPAs and product recalls by identifying and resolving the root cause with simulation Ensure restricted substances meet regional restrictions Goal: / Increased Collaboration; Faster Innovation; Customized Workflows; Optimization; Cloud & HPC

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