• Determine SaMD regulatory classification and submission pathway (e.g., 510(k), De Novo, PMA)
• Identify needs for Pre-Cert, Q-Sub, or Breakthrough Device Designation
• Develop multijurisdictional regulatory roadmap

Clinical Protocol Design

• Tailor clinical investigation plans to software endpoints
• Define accuracy, sensitivity, specificity, and usability outcomes
• Address real-world data (RWD) and real-world evidence (RWE) strategy

Technical & Algorithm Support

• Validate AI/ML model performance and bias mitigation
• Define algorithm change management strategy
• Address cybersecurity, interoperability, and data integrity

Study Operations & Execution

• Conduct feasibility, site selection, and onboarding
• Manage data flow, monitoring, and adherence in software trials
• Capture usability feedback from patients and providers

Data Analysis & Regulatory Reporting

• Perform statistical analysis of software performance
• Prepare CSRs, validation reports, and labeling evidence
• Integrate data into regulatory submissions