Publications

• An Attorney's Guide to Evaluating a Medical Device Quality Expert

Medical Device Quality and FDA Regulatory Expert

Specialties & Experience of this Expert Witness

Additional Information

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, spearheads quality management system implementations, and manages regulatory assessments and submissions, including 510(k) and PMA. Ms. Holliday’s regulatory and quality expertise make her a sought-after collegiate instructor and corporate trainer, as well as a chief technical reviewer and author for industry-leading publications. Ms. Holliday expects to earn a Master of Science degree in Regulatory Science from The Johns Hopkins University in June 2025. She holds an undergraduate degree in Chemical Engineering with a Minor in Biomedical Engineering from the University of California, Irvine. SUBJECT MATTER EXPERTISE US Food and Drug Administration (FDA) 21 CFR Health Canada SOR/98-282 Medical Device Single Audit Programs (MDSAP) EU Medical Device Regulations (MDD) The European Union (EU) Medical Devices Directive (MDD) The European Union (EU) Medical Device Regulation (MDR) ISO 14971 - Medical Device Risk Management Process ISO 13485 – Medical Device Quality Standard (QMS) ISO 9001 – Service Quality Standard (QMS) Medical Device – Global Regulatory Analysis Medical Device Verification and Validation Process QMS Program Management Clinical Trials and Evaluation Process Medical Device Design and Development Process ISO 13485 Lead Auditor ASQ – Certified Quality Auditor (CQA) ASQ – Certified Quality Engineer (CQE) FDA Post-Market Surveillance FDA Recalls and Reporting Quality Management System (QMS) Training