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Tag Archives: medical device testing

Share on Google+ July 10, 2017

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Pathology Matters, part 2 of a 3 part series: Assessing Histopathology Results

Category : Histopathology, Interventional Medicine, Medical Device testing

Part 1 of this series described the preclinical study types relying heavily on histopathology data: device safety, biocompatibility, and systemic toxicity. Here we focus on strategies for histopathology data assessment. Preclinical study histopathology data can generally be divided into three types: Qualitative Quantitative Semiquantitative Qualitative histopathology uses description to document tissue changes and is more applicable to studies where the

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Share on Google+ June 27, 2017

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FDA changes that are now in effect.

Category : FDA, Regulatory

The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act)

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Share on Google+ June 12, 2017

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Pathology Matters, part 1 of a 3 part series: Preclinical Studies and Histopathology

Category : Histopathology, Interventional Medicine, ISO, Medical Device testing

The histopathology evaluation in preclinical studies is performed to support the study objectives. The study type, tissues examined, and intended data use all determine what pathology analysis is needed. Here we review the preclinical studies that rely heavily on histopathology data. Histopathology is a key component of these preclinical study types: Device safety studies Biocompatibility studies Systemic toxicity studies These

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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+ January 23, 2017

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The APS Preclinical Program: Your Path to Success in 2017

Category : Our Laboratories

Finding a reliable partner in the preclinical CRO space can be challenging. In the early stages of product development, having a partner you can trust and rely on is of paramount importance. Welcome to American Preclinical Services. APS is an AAALAC and ISO17025 accredited, USDA registered and GLP compliant preclinical center of excellence located in Minneapolis, MN. At APS, we

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Share on Google+ September 18, 2015

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New Directions in ISO-10993-4 Hemocompatibility Testing of Medical Devices

Category : ISO

Don’t miss Kent Grove on Tuesday 9/22/15 at the 25th Annual BioInterface Workshop & Symposium. Kent will be discussing new updates in both in vivo and in vitro hemocompatibility and thrombogenicity testing. Kent was an invited speaker at the FDA workshop on Methods for Thrombogenicity Testing, held on April 14, 2014.  Kent has also championed a new minimally heparinized in

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