Fda Regulatory Compliance Expert Witnesses

Frisco, Texas

Medical Devices, Biomedical Engineering - Ophthalmology, Spinal Implants, Non-Active Implants, Cardiology, Ventilators, General Hospital, Orthopedic, Gynecology/Obstetrics, General Surgical Equipment, In-Vitro Diagnostics, Dental, Software, Neurology, Prosthetics, Sterilization, 483 Warning Letters, FDA Regulatory Compliance, FDA Approvals

Denise Holliday is a proven strategic innovator and tactical leader in highly regulated environments, including quality management systems, international regulatory compliance, and medical device risk management. As a leading medical device regulatory consultant for Capwell Consulting Group, she provides strategic support to medical technology businesses, healthcare organizations, and startups. She delivers expert testimony for medical device litigation, guiding attorneys and organizations through the complexities of the global medical device industry. Manufacturers and attorneys trust Ms. Holliday to help navigate the complex regulatory landscape of medical device manufacturing and ensure compliance with standards and guidelines. Spanning almost two decades, Ms. Holliday’s career in medical device regulatory compliance and quality assurance showcases her extensive leadership experience. She conducts ISO 13485Medical Device and ISO 9001Quality Management certification audits, spear...

Aubrey, Texas

Food, Public Health - Food Safety, Food Manufacturing, Nutrition, Foodborne Illness, Food Fraud, Food Forensics, Food Poisoning, Food Adulteration, Dietary Supplements, Food Labeling, Quality Management, Health Claims, FDA Regulatory Compliance, USDA Regulatory Compliance, Food manufacturing standard practice, Foodservice standard practice, Foodservice

I am a senior level food scientist with experience in the food regulatory, food manufacturing, and food service sectors. I am also a Registered Dietitian and nutrition scientist. I am a well-regarded and accomplished expert witness with more than 80 litigation cases, having testified at trial and deposition almost 40 times. My broad scope with diverse background makes me ideally suited for challenging cases where it is important or helpful to be able to integrate information from a number of different disciplines. My professional experience is truly unique, and my credentials and experience make me unimpeachable. I enjoy deposition and trial, understanding the art of the exercise; and I work to deliver the optimal results for my clients.