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FlightBlog

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Experienced researchers and technicians are at your service when you partner with American Preclinical Services. You gain one-stop access to full biocompatibility, interventional, and surgical research and pathology services within a world-class facility. ISO 17025 accredited, AAALAC accredited, USDA licensed, and GLP compliant, American Preclinical Services offers you the bundled resources you require to achieve rigorous medical device testing in a single laboratory operation.

Share on Google+ May 22, 2017

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Dystrophic Mineralization of Costal Cartilage in Hartley Guinea Pigs

Category : Histopathology, Publication, Toixcology

The University of Minnesota College of Veterinary Medicine and American Preclinical Services collaborate to document a previously undocumented novel lesion of Hartley guinea pigs, dystrophic mineralization of costal cartilage, as an incidental finding.  Abstract Hartley guinea pigs are widely used animal models of disease, particularly in studies of osteoarthritis. The purpose of this study was to investigate lesions in the

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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+ April 10, 2017

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CHARACTERIZATION OF EXTRACTABLES AND LEACHABLES: CHALLENGES and SOLUTIONS

Category : APS Service Offerings, Our Laboratories

Chemical characterization of Extractables and Leachables (E&L) with the corresponding toxicological risk assessment are already mandated by regulatory agencies to ensure patient safety and successful submissions for medical devices. FDA regulations, USP and various ISO Standards namely 10993 part 18: Chemical Characterization of Materials, provide guidance to perform characterization of E&L. Extractables are compounds that are released from a device

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Share on Google+ April 3, 2017

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FDA CDRH Experiential Learning Program is open for comments

Category : FDA, Medical Device testing

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced on March 23, 2017 that the submission period for Experiential Learning Program (ELP) in open. ELP is a training component intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, patient perspective/input, quality system management, and other challenges that impact the device

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Share on Google+ March 29, 2017

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FDA Regenerative Medicine Advanced Therapy (RMAT) Designation is now live

Category : FDA

FDA Regenerative Medicine Advanced Therapy (RMAT) Designation is now live. Regenerative medicine encompasses a wide scope of innovative products including: cell therapies e.g., chimeric antigen receptor T-cells (CAR-T cells) and human tissues grown on scaffolds therapeutic tissue engineering products human cell and tissue products certain combination products using such therapies Recognizing the importance of Regenerative Medicine, Congress included several provisions

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Share on Google+ March 27, 2017

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Introducing the New APS FlightLog Portal: Performing Biocompatibility Just Got Easier!

Category : APS Service Offerings, Our Laboratories

Did you know that APS provides ISO 10993 biocompatibility testing for the medical device and biotechnology industry?  We have developed a unique process for biocompatibility test panel creation, sample submission, and study reporting via our online APS FlightLog Portal. Recently this system has been improved by adding an integrated dashboard and optimizing the user interface. Two-step submission process: This feature was put in place

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