Consulting Specialties
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Device, Drug, and Biologic Combination Product Development Strategy (delivery platform selection, bridging strategy, threshold analysis), Design Controls (DHF), Risk Management, Cybersecurity and Assurance Cases
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​Regulatory and Clinical Strategy Development and Regulatory Submissions
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​Digital Health, SaMD, Connected Health, and Artificial Intelligence(AI) System Safety, Cybersecurity, and Compliance
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Global Product Risk Management Compliance and Best Practice Training, Assessment and Implementation
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​System engineering (system architecture design, requirements management, verification and validation testing management)
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​Clinical Risk Assessment/Rationale, Benefit vs Risk Analysis
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​Pre-Market Approval/Clearance Issue Resolution and Post-Market Issue Remediation
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