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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