Clinical, Regulatory and Quality Systems Strategists

  • Clinical Study Plans
  • Study Design and Protocol Development
  • Study Management
    • High and Moderate Complexity Devices
    • Point of Care Devices
    • Over the Counter and At-home Devices
    • Usability Studies
    • Reproducibility Studies
  • Study Reports
  • Data Management Plans
  • Statistical Analysis Reports
  • EDC Support
  • Data Analysis and Visualization
  • Regulatory Strategy
  • Regulatory Submissions
    • Breakthrough Device Designation
    • STeP Program
    • Pre-submission
    • Pre-submission Supplement
    • 510(k)
    • De Novo
    • PMA
  • FDA Registration and Listing
  • US Agent Representation
  • IVDR Gap Analysis
  • Technical File Support
  • QMS/eQMS Strategy and Implementation
  • eQMS Platform Selection
  • IVDR QMS Compliance
  • Certifications ISO 13485, ISO 9001, ISO 17052, MDSAP, IVDR
  • Registrar and Notified Body Selection
  • Internal Quality Audit Management (IQA)
  • CAPA Management and Audit Remediation
  • FDA Warning Letter Support and Remediation
  • Product Recalls and Withdrawal
  • CLIA Lab QMS Accreditation
  • Clinical Site Network
  • Specimen Sourcing
  • Market Research
  • Market Access
  • Key Opinion Leaders
  • Software Review and Submission Guidance
  • Analytical Study Support
  • CLIA Lab Setup

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