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WHERE MEDICAL INNOVATIONS TAKE FLIGHT

preclinical

APS’ Continued Commitment to quality

APS Receives FDA Clean Bill of Health

APS is committed to quality. In March 2014, APS was inspected by the FDA for compliance to 21 CFR Part 58, FDA Good Laboratory Practice. During this multi-day inspection, the FDA thoroughly reviewed APS’ quality systems. The outcome of this audit demonstrated that APS was in full compliance with no deficiencies being identified.

APS strives to provide exceptional preclinical research services. We bring together a first rate facility, state of the art medical diagnostic imaging, unparalleled technical expertise and a strong quality and compliance mindset. We understand that often these services directly impact the quality and contents of our customer’s regulatory strategies and submissions. APS conducts well designed, well documented studies and remains on the leading edge of preclinical research by delivering high quality studies. Our recent interactions with FDA validate our stance that APS continues to be a leader in field of medical device preclinical testing and is able to deliver GLP compliant studies for even the most challenging programs.

 

APS’ Presentation on Methods for Thrombogenicity Testing

APS remains dedicated to the advancement and refinement of medical device testing. On April 14, 2014 Kent Grove, Director of Biocompatibility, presented during the public workshop on Methods for Thrombogenicity Testing hosted by the FDA at the White Oak Campus in Maryland. Mr. Grove’s presentation focused on alternative surgical and interventional procedures for the evaluation of thrombogenicity of contemporary medical device technologies.

Mr. Grove’s individual presentation can be viewed here on the APS website. The entire workshop can be viewed on the FDA’s website.

 

Canine Jugular Vein filled with contrast
Canine Jugular Vein filled with contrast