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Category Archives: APS Service Offerings

Share on Google+ March 13, 2018

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APS Adds Capacity, Capabilities, and Competencies to its Research Campus

Category : APS Service Offerings

American Preclinical Services (APS) is proud to announce the addition of a new cath lab, 25,000 sq ft of new laboratory space, 11,000 sq ft of new large animal housing capacity and a new Director of Toxicology. Located within the APS research campus, the new laboratory space will include a 7,000 sq ft analytical lab, a 5,000 sq ft in-vitro

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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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American Preclinical Services Discusses 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+ 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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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+ June 3, 2015

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Computed Tomography (CT) Imaging in Preclinical Research

Category : APS Service Offerings, Cardiology, In-vivo Testing, Interventional Medicine, Medical Device testing

Computed Tomography (CT) scanners have been in use for over 40 years and when it comes to aiding in clinical diagnosis, has changed the face of medical imaging. CT scans provide a higher level of detailed images than with standard X-ray or fluoroscopy. This holds especially true in the case of organs, blood vessels and muscle beds. CT scanning, when

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