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Regulatory Services

Post-approval Support

  • Postapproval Study

    Postapproval clinical studies are often required as a condition of approval of a PMA. We have experience designing postapproval studies for devices used across many clinical applications.

  • Publication Support

    Our team can assist with the editorial and technical aspects of writing manuscripts that report the results of clinical or non-clinical studies for peer-reviewed medical journals. We have assisted with over two dozen published articles, including co-authoring articles in such journals as the Journal of Vascular Surgery, the Journal of Urology, Gastrointestinal Endoscopy, and the European Journal of Vascular and Endovascular Surgery.

  • 522 Study

    522 studies are post-market surveillance studies that are sometimes required for certain already-approved devices. The FDA will typically order a 522 study if there are questions of specific concern involving the device.

    Our team has designed several 522 studies and has managed correspondence with the FDA throughout the studies.

  • Reclassification Petition

    Any interested party can request that all devices of a given type be reclassified (for example, from Class III to Class II). Such petitions involve summarizing the existing information on the device and demonstrating that the reclassification is warranted.