Past project.

IVD Platform Development & FDA Regulatory Strategy

IntelligentMDx

Problem
Company required rapid development of a QPCR-based diagnostic platform under FDA constraints.

Solution
Led R&D team for $25M IVD platform development.

Strategy

●      Built and managed cross-functional scientific team

●      Designed validation protocols (LoD, specificity, stability)

●      Ensured compliance with FDA, cGLP, ISO 13485, CLIA

●      Accelerated timeline to regulatory readiness

Outcome / Impact

●      Achieved rapid development milestones

●      Contributed to industry recognition for speed to market