Denise Holliday

Denise Holliday, Regulatory Affairs Certification RAC-DEVICES, ISO 13485:2016 Lead Auditor Certification, ISO 9001:2015 Lead Auditor Certification, Certified Quality Auditor Certification, Certified Quality Engineer Certification, Six Sigma Green Belt is a medical device regulatory compliance and risk management expert specializing in litigation support for medical technology businesses, healthcare organizations, and startups. With a career spanning quality management systems, international regulatory compliance, and medical device risk management, she brings a strategic framework to her litigation work. Her work centers on conducting ISO certification audits, spearheading quality management system implementations, and managing regulatory assessments.

Ms. Holliday has been retained in numerous expert witness and consulting engagements across the United States, involving medical device manufacturing, compliance, and litigation support. Her Master of Science in Regulatory Science from The Johns Hopkins University, along with her certifications, reinforce her ability to deliver objective, defensible analyses. She is regularly engaged by both plaintiff and defense counsel to provide clear, independent determinations of regulatory compliance and risk management in disputes involving medical devices.