Regulatory Affairs

A sound regulatory strategy sets the foundation for successful health care innovation. This is particularly relevant when developing medical devices including highly sophisticated In Vitro Diagnostic (IVD) products, as well as Laboratory Developed Tests (LTDs), individualized medicines and traditional medical devices that face increased oversight and evolving regulations. Beaufort supports successful scientific innovation for medical device and IVD companies in the U.S. and beyond, serving areas including Europe, South America, Australia, New Zealand, Canada and the Asia-Pacific.

To meet your project goals, Beaufort will create and implement customized product development plans for IVD assays and instrument platforms as well as customized plans for traditional medical devices, including combination products. From preparing regulatory strategies, to providing regulatory submission support and working with global regulatory agencies to achieve your marketing objectives, we deliver unparalleled expertise. With initial proactive interactions with regulatory agencies and prompt consultation throughout the project, we will enable you to achieve your desired outcomes.

Services We Provide Include:

  • Regulatory strategy development
  • Device classification
  • Intended use statement development
  • Predicate device identification
  • Clinical protocol design
  • Regulatory submission preparations
    • Pre-submissions
    • Investigational device exemption (IDE)
    • 510(k) Premarket notification
    • De novo (evaluation of automatic Class III designation)
    • Premarket Approval Application (PMA)
    • Request for Designation (RFD)
  • Regulatory agency liaison
  • Decision tree analysis guidance
  • Post-market support
  • Regulatory consulting and training
  • Statistical support (sample size and SAP development)

 

Read case studies of how Beaufort has helped clients meet their Regulatory needs.