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    Custom Control Manufacturing

    We meet the needs of In Vitro Diagnostic manufacturers as well as end users with our custom manufactured controls. We utilize our reliable base matrices and are able to achieve flexibility for a wide range of analytes.

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    Advantages of a manufacturing partnership with us include:

    Strategic flexibility

    Iterate and prototype more of your own products with time saved manufacturing

    Agile response times

    Begin your pilot production quickly with short lead times on custom material

    Free up internal resources

    Devote more of your manufacturing resources to critical tasks
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    Our Process

    Design

    • Safety and effectiveness of product
    • Basematrix selection
    • Analyte and Target Levels, # of Levels, Stabilizers, Packaging
    • Form: Liquid or Lyophilized

    Pilot Production

    • 1st Pilot – Confirm specifications achievable
    • 2nd Pilot – Use approved manufacturing instructions, Duplicate 1st Pilot
    • 3rd Pilot – Bulk Lot

    Regulatory Submission

    • 510K/CE Mark Approval sought as needed
    • Compile data from 3 Pilots and submit for approval

    Bulk Production

    • Continued performance testing including real-time stability

    Change Request

    Determine if change is:
    • Feasible
    • Requires design changes
    • Validated in pilot production
    • Requires new regulatory submission
    • Approval by customer