Beaufort Solution: After identifying pathways to a Class II device classification, Beaufort prepared a strategic regulatory plan for the test kit, enabling the company to satisfy regulatory requirements in a cost-effective manner.  Beaufort drafted a pre-IDE filing, including a clinical trial plan, and provided coaching to the client as it prepared for its pre-IDE meeting with the FDA.  After successful meetings with FDA officials, the company relies on Beaufort for continued support as necessary, including assisting with preclinical and clinical trial activities.