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ICONACY has made every effort to source referenced material from health professionals. ICONACY operates to the applicable standards of the European Medical Device Directive (EU93/42), all applicable regulations promulgated by the U.S. Food and Drug Administration (FDA), and has implemented a quality system in compliance with the applicable requirements of ISO 13485 and the U.S. FDA's Quality System Regulation. These set out quality requirements which are specific to medical devices.
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