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WHERE MEDICAL INNOVATIONS TAKE FLIGHT

preclinical

APS Participates in Bike-A-Thon

APS recently participated in a Bike-A-Thon Spin Class in support of YMCA’s community programs.   The bike-a-thon was held on Saturday, February 6, at the Emma B Howe location of the YMCA in Coon Rapids, MN. “In addition to the great service our company does to the medical research community, APS also desires to support worthwhile […]

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New Guidance! FDA New Guidance for Industry, General Considerations for Animal Studies for Medical Devices

On October 14, 2015, FDA released a draft guidance entitled, “General Considerations for Animal Studies for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff“.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 […]

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ISO/TC 194 – Biological and Clinical Evaluation of Medical Devices

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 […]

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