Experience

A Sampling of Our Experience:

Clinical Application

Our Role

Biologic Stem Cell Therapy
Quality Assurance Clinical Study Data Audit
Biologic Wound Care Device
Senior Quality Management Recruitment, FDA/ISO Quality System development, Supplier/Testing Laboratory Network
Ex Vivo Imaging System
Embedded Vice President, Regulatory and Clinical Affairs; Regulatory Strategy, Quality Supplier Qualification, Product Development Expertise
Heart Failure Monitor for Home Use
Clinical Study Process Development, Investigator and Site Recruitment
Interventional Cardiology
FDA Regulatory Strategy, Predicate Identification, Product Development Plan, Project Management
Non-Invasive Stroke Therapy
FDA Regulatory Strategy, IDE Pre-Submission and Lead, Design Control Expertise
Over-the-Counter Women’s Health
FDA 510(k) Regulatory Strategy, Product Development Plan, Budgeting , and Management
Wireless Temperature Monitor
FDA 510(k) Regulatory Strategy and Submission, Quality System, Design Control Program Management

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