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Consulting Specialties

  • Device, Drug, and Biologic Combination Product Development Strategy (delivery platform selection, bridging strategy, threshold analysis), Design Controls (DHF), Risk Management, Cybersecurity and Assurance Cases

  • ​Regulatory and Clinical Strategy Development and Regulatory Submissions

  • ​Digital Health, SaMD, Connected Health, and Artificial Intelligence(AI) System Safety, Cybersecurity, and Compliance

  • Global Product Risk Management Compliance and Best Practice Training, Assessment and Implementation

  • ​System engineering (system architecture design, requirements management, verification and validation testing management) 

  • ​Clinical Risk Assessment/Rationale, Benefit vs Risk Analysis

  • ​Pre-Market Approval/Clearance Issue Resolution and Post-Market Issue Remediation

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