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Share on Google+ February 13, 2019

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BSI achieves successful Medical Devices Regulation (MDR) designation in the UK

Category : Uncategorized

On Monday, February 11, 2019, BSI reported that they heard from the MHRA that BSI is now designated to the MDR (EU 2017/745) in the market leading UK Notified Body (0086).  BSI has been designated for the full scope they applied for in November 2017. Please see the NANDO information system for further details. BSI will very shortly confirm when

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Share on Google+ August 28, 2017

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American Preclinical Services Receives AAALAC’s Global 3Rs Award for North America.

Category : Coronary Artery Disease, Uncategorized

American Preclinical Services (APS) has been awarded AAALAC’s Global 3Rs Award for all of North America (there are two-three other winners for other continents). This AAALAC award recognizes our development of a new testing methodology, the In-vitro Blood Loop Assay, as a replacement for the Canine NonAnticoagulated Venous Implant (NAVI) Model for testing thrombogenicity of medical devices. This is truly a

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Share on Google+ August 7, 2017

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Pathology Matters, part 3 of a 3 part series: Semiquantitative Histopathology Scoring

Category : Uncategorized

Preclinical studies generating semiquantitative histopathology data are welcomed by regulatory agencies because, theoretically, reproducible and comparable results would be obtained with independent observers. But is that necessarily the case? Many factors influence the interpretation and reproducibility of semiquantitative data. Histopathology results are dependent on establishing appropriate scoring criteria. Semiquantitative scoring, with categorical ranking of observed changes, is also subject to

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Share on Google+ April 4, 2016

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Get The Most Out of Your Pathologist

Category : Uncategorized

The pathologist’s primary role in a preclinical study is interpreting gross and microscopic tissue changes. But did you know that the pathologist can also be a valuable resource for study planning? Consultation with an experienced pathologist early in the study, ideally during protocol development, contributes to getting the most data for your research dollar. Benefits to all parties include: Selection

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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+ August 13, 2015

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Quality Makes the Difference

Category : Uncategorized

American Preclinical Services believes that quality makes the difference and our approach is what sets us apart. At APS, quality is collaboration between all APS employees. We are continually working as a team to monitor quality, identify areas for improvement, implement solutions and improve quality. See What Sets Us Apart! Weekly operations and scientific meetings to review study initiation and

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