Meet Our Team
Our team combines regulatory strategy with hands-on AI/ML validation engineering, aligned by a shared focus on traceability, risk discipline, and structured lifecycle execution. We believe compliance and innovation should advance together — using automation and AI responsibly to accelerate development while preserving control, clarity, and regulator readiness.
Jay’s regulatory leadership brings extensive experience in medical device quality systems, Software as a Medical Device (SaMD), and AI-enabled healthcare technologies. With a background in ISO 13485, IEC 62304 lifecycle architecture, risk management alignment, and FDA submission readiness, our focus is building structured, defensible compliance systems that integrate engineering and quality from the outset.
Core Focus Areas:
QMS architecture and implementation
Design controls and DHF structuring
ISO 14971 risk framework integration
FDA readiness strategy
AI governance and compliance alignment
Jay Freelong
Regulatory & Systems Architecture Lead
Ashoka, our Lead Validation Engineer brings over a decade of experience in medical device software development, test automation, and AI/ML dataset verification within highly regulated environments. Specializing in risk-based verification strategies and automation frameworks, this role ensures technical systems are traceable, defensible, and regulator-ready.
Core Focus Areas:
AI dataset verification and validation
Automation framework design
Risk-based V&V strategy development
Requirements traceability integrity
System and user acceptance testing oversight
Ashoka Vardhan Pasupula
AI/ML Validation & Automation Engineering Lead