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Category Archives: In-vitro testing

Share on Google+ October 24, 2018

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Improved Method for the ASTM Platelet and Leukocyte Assay: Use of Minimal Heparinization in a Screening Test for Hemocompatibility of Blood-Contacting Medical Devices

Category : Biocompatibility, In-vitro testing

Abstract Most blood-contacting medical devices must be assessed for potential thrombogenicity prior to regulatory approval. A common assay for screening and qualifying devices involves monitoring the reduction of platelet and leukocyte counts in whole blood exposed to the device. We have validated an improved method for assessing a device’s effect on platelet activation and surface adhesion, offering significant improvement over

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Share on Google+ May 8, 2017

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An Update From The APS In-Vitro Testing Laboratory

Category : APS Service Offerings, FDA, GLP, In-vitro testing, Our Laboratories

The In-vitro Testing Laboratory has had a busy start to 2017. Most recently, we presented at the Society of Toxicology (SOT) conference on the improvements of the multiple hemocompatibility tests, including the In-vitro Blood Loop Assay and Platelet/Leukocyte Count Assay. Collaboration with the FDA is ongoing for the In-vitro Blood Loop assay – we have submitted our methods and protocol

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Share on Google+ June 29, 2015

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ISO/TC 194 – Biological and Clinical Evaluation of Medical Devices

Category : APS Service Offerings, In-vitro testing, In-vivo Testing, ISO, ISO/TC 194, Medical Device testing

APS Staff participated in the annual gathering of Technical Committee 194 of the International Standards Organization which is responsible for the continuing development and revisions of the guidelines for “Biological and Clinical Evaluation of Medical Devices”. The output of this committee and the associated 17 working groups is critical in the global processes standardizing biological test methods for the evaluation

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Share on Google+ July 26, 2013

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All ISO 10993 Thrombo Study Designs Are Not Created Equal

Category : In-vitro testing, In-vivo Testing, Study Design Consulting, Study Management

The in-vivo thrombogenicity assay is a widely used method for screening the ability of blood contacting medical devices to cause a clot upon implantation. The in-vivo thrombogenicity assay is designed to evaluate the thrombogenicity potential of a medical device in comparison to a predicate device already on the market. As medical devices continue to become more advanced, the clinical relevance

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