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Makromed, Inc. was a specialized medical device contract research organization (CRO) and regulatory consulting firm based in Danvers, Massachusetts. Founded in 1996, the company provided comprehensive regulatory, clinical, and quality assurance services to the medical device and diagnostic industries globally. Makromed was recognized for its deep expertise in navigating complex FDA regulatory pathways, including 510(k) and PMA submissions, as well as international compliance requirements. In October 2013, the company was acquired by NAMSA (North American Science Associates), a leading global medical research organization. The acquisition integrated Makromed's specialized consulting capabilities into NAMSA's broader service portfolio, particularly strengthening its presence in the Northeast United States.
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