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.

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 1497 - 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

PRODUCT EXPERTISE
Ophthalmology
Spinal Implants
Non-Active Implants
Cardiology
Ventilators
General Hospital Process
Orthopedics
Gynecology/Obstetrics
General Surgical Equipment
In-Vitro Diagnostics
Dental
Medical Device Software
Neurology
Prosthetics
Sterilization Processes

REGULATORY AND COMPLIANCE EXPERTISE
483 and Warning Letter Issuance
Consent Decree Litigation
FDA Registration and Listing Matters
FDA Approval and Clearance Disputes