Denise Holliday

About Denise Holliday

Denise Holliday is a proven strategic innovator and tactical leader in highly regulated…

Experience

1. Expert Witness

   Capwell Consulting Group

   Aug 2024 — Present

   Capwell Consulting Group is the premiere medical device, regulatory compliance, and risk management consulting service in the quality assurance and regulatory affairs industries. Ms. Holliday’s responsibilities include strategic consulting in medical device manufacturing and compliance, litigation support and expert testimony within regulatory compliance framework.• Expert consultant within the international medical device, regulatory compliance, and risk management industries.• Specializes in quality management systems, international regulatory compliance, risk management, and technical documentation for all classes of medical devices.• Certified and experienced auditor adept at analyzing compliance with Food and Drug Administration (FDA) and global regulations, including interactions, licensing, certifications, submissions, and reporting.• Provides expert testimony and reporting for litigation involving medical technology companies, healthcare organizations, and startups.• Consults on the development, implementation, management, and continual improvement of ISO 13485 Medical Device Quality Management Systems – Requirements for regulatory purposes.• Consults on the development, implementation, management, and continual improvement of ISO 9001 Quality Management System (QMS) Standards.

Education

• The Johns Hopkins University

  Master of Science - MS, Regulatory Science

• University of Southern California

  Doctorate, Regulatory Science

• UC Irvine

  BS, Chemical Engineering, Biomedical Engineering

  1998 — 2003