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
-
​Model-Based Systems 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
