Denise Holliday Medical Device Quality Litigation Expert

Medical Device and Regulatory Compliance Expert

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 more than 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.

As President and CEO of Schuler Medical Device, Ms. Holliday provides pivotal regulatory and quality expertise to ensure successful product launches for medical device organizations worldwide. She oversees recall and remediation assistance, ensuring that companies meet and exceed regulatory standards. In her earlier senior-level engineering roles, she led design and development activities for Class I, II, and III medical devices, managed quality and validation plans, and oversaw critical non-project activities. She is instrumental in ensuring products meet rigorous FDA and international standards.

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.