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Tag Archives: medical device

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+ 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 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+ September 9, 2015

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APS Publishes First Guidance Document: Recommendations for the Evaluation of Investigational Heart Valves

Category : Cardiology

Scope: This guidance applies to both surgical and percutaneous delivered heart valves and other valve repair technologies. Experience:  APS conducts 150+ non-GLP/GLP valve repair or replacement procedures per year. Imaging:  APS has three Siemens digital cath lab suites, an experienced echocardiographer and a 128-slice Siemens Dual Source CT scanner. APS publishes the first in a series of preclinical research guidance documents

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Share on Google+ August 18, 2015

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BioInterface Conference Coming to Arizona

Category : ISO

The 2015 Biolnterface Conference is the hallmark annual event of the Surfaces in Biomaterials Foundation (SIBF). This year’s conference – the 25th Anniversary of the event – is scheduled for September 21-23 at the Fairmont Scottsdale Princess in Arizona. The BioInterface Conference kicks off with Workshops on Monday, Sept. 21. The theme of this year’s Workshops is Hemocompatibility Technologies, Models

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