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European Authorized Representative
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Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium.
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CL Tech Inc.
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Provide qualification, compliance, regulatory, training, and validation services to pharmaceutical, medical device, and biotechnology industries. Specializing in facility, equipment and Part 11 validations.
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Biotech Consultant LLC
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Biotech Consultant LLC provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, pharmacogenomics, analyte specific reagent (ASR) regulatory compliance, and proteomics), medical device software (including bioinformatics), CPT coding reimbursement, and biotechnology-based products.
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