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The CRO Group Inc. - crogroup.com
Medical device, IVD, and biotechnology consulting in quality, regulatory, safety testing, clinical investigations, reimbursement, export, compliance, approvals, ISO9000, EN46000, ISO13485 certification, CE Marking, 21CFR820, 21CFR812, authorized representative, software-qa, mdr-vigilance, and ipo-venture capital audit preparations
iso 13485 cmdcas ivd directive 510k en 60601-1-4 21 cfr 11 21 cfr 812 21 cfr 820 part 11 eu authorized representative fda us agent technical files quality systems safety testing 93-42-eec 98-79-ec
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