Your global partner for medical device development

A robotic arm holds a medical scalpel.

Your breakthrough. Our best-in-class solutions.

Beaufort’s specialized expertise and shared commitment to accelerating life-changing innovations has enabled medical device manufacturers to bring the most advanced technologies to fruition. We have supported our clients in successfully developing hundreds of medical device products across major and niche therapeutic indications. 

Our comprehensive clinical trial services provide the strategic guidance and operational excellence needed to effectively lead your medical device research programs through the full development process. We also bring decades of experience communicating with regulatory bodies and identifying how to best perform clinical pilot, pivotal, and post-market studies and collect the data to support your product’s submission to regulatory bodies worldwide.

Flexible solutions to better navigate today’s evolving device landscape

  • Clinical Trial Management
    • Protocol development
    • Site identification, qualification and selection
    • Site contract and budget negotiation
    • Central laboratory selection and management
    • Trial monitoring (site Initiation & protocol implementation, interim monitoring, site close-out)
      • Safety data review and reporting
      • Data safety monitoring board (DSMB) preparation and coordination
      • Clinical events committee (CEC) preparation and coordination
  • Data Management
    • eCRF development
    • Database design, build, UAT, validation and release
    • Data review and cleaning
    • Database lock and transfer
    • API set-up and management
  • Biostatistics
    • Statistical analysis plan (SAP and interim analysis plan preparation
    • Data analyses
    • Preparation of tables, listings and figures
    • Clinical study report preparation

  • Regulatory strategy development
  • Device classification and conformity assessments
  • Predicate device identification
  • Regulatory agency liaison
  • Regulatory pre-submission/submission support:
    • Early FDA (CDRH) engagement – pre-submission and pre-IDE planning
    • 510(k)
    • De novo
    • Premarket approval (PMA) and supplements
    • Pre-EUA/EUA
    • CLIA waiver
    • Q submissions
  • Technical files/dossiers /IVDR technical documentation (CE Marking)
  • Medical device license (MDL)
  • Humanitarian use device (HUD), humanitarian device exemption (HDE), and breakthrough designation support
  • Investigational device exemption (IDE)
  • Analytical testing requirements, protocol development and review
  • Post-market support

  • QMS design and implementation
  • Quality system regulation (QSR) audits
  • Gap assessment and remediation
  • Inspection readiness
A scientist holding a sample container verifies the accuracy of information on a computer screen.

Broad experience to meet your unique program needs

Medical Specialties

  • Cardiovascular
  • Ear, nose and throat
  • General and reconstructive surgery
  • General hospital
  • Women’s health
  • Ophthalmology
  • Orthopedic


Areas of Expertise

  • Implantable devices
  • Surgical tools, systems, and accessories
  • Drug delivery devices
  • Diagnostic imaging and monitoring devices
  • Medical device software, wireless systems, and mobile medical applications
  • Artificial intelligence and machine learning (AI/ML)