In addition, ICON Medical Imaging senior management is actively participating in the development of industry standards working with the MCC, PhRMA, FDA, DIA, and the Imaging Core Labs to create standards for charters and submissions. Our clients can expect expert, timely information with regard to current thinking at FDA and regulatory authorities around the world.
ICON Medical Imaging was audited by FDA in February 2011, June 2009, October 2008 and August 2002. No 483s or other findings were issued. FDA audits involving imaging are complex due to the amount of data that is captured throughout the trial. ICON Medical Imaging’s proven processes and procedures ensure that this process will be as seamless as possible for all involved parties involved in the audit process.
ICON Medical Imaging monitors and continually updates our processes with current industry practices and assessment criterias including:
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ICON Medical Imaging is ISO 9001:2008 certified. ISO 9001:2008 certification is rarely seen among Medical Imaging Core Laboratories. Our ISO 9001:2008 certification recognises ICON Medical Imaging's ongoing commitment to quality, reliability and continual improvement of all processes while maintaining transparency for better customer satisfaction.