Cdrh-rst.fda.gov

RST Catalog Search Center for Devices and Radiological Health

WEBAn In Vitro Blood Flow Loop System for Thrombogenicity Evaluation of Medical Devices and Biomaterials. This tool provides a step-by-step protocol to design a recirculating flow …

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URL: https://cdrh-rst.fda.gov/search

Regulatory Science Tools Catalog Center for Devices and …

WEB2. 3. For more information about the Catalog of Regulatory Science Tools, email [email protected]. The Catalog of Regulatory Science Tools provides a peer …

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Workflow for Assessing the Credibility of Patient-Specific …

WEBFor more information about the Catalog of Regulatory Science Tools, email [email protected].. The Catalog of Regulatory Science Tools provides a peer …

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Validation Framework for Epidemiological Models Center for …

WEBTechnical Description. This tool comprises Python software for retrospective validation of epidemiological models, such as models that predict number of COVID-19 deaths or …

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Device and Material Safety Evaluation Library (DAMSEL)

WEBThe DAMSEL tool is not intended to make specific recommendations for designing novel medical devices, but instead provides collated information to assist innovators in their …

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2D Human Induced Pluripotent Stem Cell-derived Cardiomyocyte …

WEBCatalog of Regulatory Science Tools to Help Assess New Medical Devices . This regulatory science tool presents a lab method to assist with evaluating and quantifying contractile …

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MIDA: A Multimodal Imaging-Based Model of the Human Head …

WEBCatalog of Regulatory Science Tools to Help Assess New Medical Devices . This regulatory science tool presents a computer model of the human head and neck that can facilitate …

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Benchmark dataset for validating computational fluid dynamic …

WEBCatalog of Regulatory Science Tools to Help Assess New Medical Devices . This regulatory science tool presents a dataset for validating computational fluid dynamic (CFD) …

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Chemicals List for Analytical Performance (CLAP)

WEBTechnical Description. CLAP is a collection of over 100 example chemicals that have been characterized in CDRH laboratories and are provided with the following information: …

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Color Performance Review Tool for Endoscopy Devices

WEBCatalog of Regulatory Science Tools to Help Assess New Medical Devices . This regulatory science tool presents a computer model for analyzing color measurement data to …

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TSL/EED/MOS (TEEM) Calculator Center for Devices and …

WEBThe TSL/EEDmax/MOS (TEEM) Calculator is a web-based toxicological risk assessment tool that applies these equations to chemical extractables data to facilitate consistent …

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Regulatory Science Tools Catalog Center for Devices and …

WEBThe Virtual Imaging Clinical Trials for Regulatory Evaluation (VICTRE) computer modeling pipeline is a set of tools that allow for the replication of clinical trials of in silico breast …

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CHemical RISk calculators (CHRIS) – Extraction Efficiency

WEBCatalog of Regulatory Science Tools to Help Assess New Medical Devices . This regulatory science tool presents a computer model that allows the user to compare the theoretical …

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CHemical RISk calculators (CHRIS) – Bulk Chemicals (v2)

WEBThe CHemical RISk calculator (CHRIS) – Bulk Chemicals (version 2) enables users to conduct screening level risk assessments by providing immediate feedback on whether …

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An In Vitro Blood Flow Loop System for Thrombogenicity …

WEB2.3 Blood preparation. Human donor blood and four types of animal blood had been used in our verification studies (See Table 2 below).The human blood (obtained from the …

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Mock Circulatory Loop Generated Database for Dynamic …

WEBFor more information about the Catalog of Regulatory Science Tools, email [email protected].. The Catalog of Regulatory Science Tools provides a peer …

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BoneJ Headless: An Automated Python Tool for Bone …

WEBFiji is an open-source image processing software with several downloadable plugins for image analysis. One of these plugins is BoneJ, which is capable of computing several …

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