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Assisting the Medical Device Community with FDA regulatory services. Working Worldwide Since 1990. FDA Submissions: 510(K), IDE, PMA, Product Reports. (Over 300 successful 510(k) clearances). See additional 510(k) information below. Medical Device License Submissions for CANADA: Canadian Medical Device License Information. Barcodes now required on most medical devices. FDA 483 and WARNING LETTER: Strategies and Responses. CGMP Compliance Programs: AUDITING - CONSULTING. The fee changes each year. Sterili...
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