483 Warning Letters Expert Witnesses
483 warning letters expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on 483 warning letters. The 483 warning letters expert witness listings on this page are typically from fields/areas of expertise such as: General Practice and Medical Devices.
Denise S. Holliday
Medical Device Quality and FDA Regulatory Expert
Capwell Consulting Group LLC
Frisco, Texas
Medical Devices, General Practice
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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...
