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Medical Devices Solutions Presentation

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Regulatory Affairs Regulatory Compliance • Tools: Simulation process and data management platforms, collaboration and administration tools, quality assurance test suites • Ease of Use: Workflow automation, data sharing, data archiving, automated reporting • Meet regulatory expectations for computational modelling (ASME V&V 40) • Incorporate verification, validation and uncertainty quantification (VVUQ) best practices • Establish managed and traceable computational modelling workflows • Automated model report generation that satisfies regulatory guidance requirements • Proven track record of supporting approved regulatory applications • Ansys is actively collaborating with global regulators to advance the credible use of digital evidence Customer Goals Solution Benefits

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