Freyr, as a proven Regulatory partner, provides end-to-end Medical Device Regulatory services that span across decoding Medical Device classification, compiling Device documentation, Medical Writing, Device Registration and acting as an in-country representative. We customize the process with respect to service and software assistance for end-to-end device approvals. With the Freyr offices located across the continents, Freyr offers regulatory services for Market Entry and regulatory compliance across all regions. The resources consist of a mixed pool of expertise offering one stop solution for all the regulatory needs.

Global Medical Device Centre of Excellence Expertise

  • Global Regulatory Intelligence

    Global Regulatory Intelligence

  • Medical Device Classification

    Medical Device Classification

  • Document Compilation

    Document Compilation

  • Medical Writing

    Medical Writing

  • Quality Management System

    Quality Management System (QMS
    of Medical Devices

  • In-Country Representation

    In-Country Representation

  • Medical Device Labeling and Review

    Medical Device Labeling and Review

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About Medical Device Regulatory Services