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Category Archives: Study Management

Share on Google+ October 16, 2015

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New Guidance! FDA New Guidance for Industry, General Considerations for Animal Studies for Medical Devices

Category : FDA, GLP, In-vivo Testing, Medical Device testing, Study Management, Uncategorized

On October 14, 2015, FDA released a draft guidance entitled, “General Considerations for Animal Studies for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff“.  The purpose of this document is, once final, to supercede FDA’s current Guidance entitled General Considerations for Animal Studies for Cardiovascular Devices, which was issued on July 29, 2010. The Big Picture

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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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