About
Ms. Holliday has over two decades of expertise in Medical Device Manufacturing, FDA Compliance, and Risk Management. Denise focuses on litigation centered around wrongful death, safety, medical device hazards, and design and development quality. She currently serves as an expert witness consultant for Capwell Consulting Group LLC.
Ms. Holliday lends her expertise to her clients from her career spanning over 2 decades in the highly regulated field of medical device quality management systems, international regulatory compliance, quality assurance, and medical device risk management. As a medical device regulatory consultant for Capwell Consulting Group, she provides strategic litigation support to medical technology businesses, healthcare organizations, and startups. She conducts ISO 13485 Medical Device and ISO 9001 Quality Management certification audits, spearheads quality management system implementations, and manages regulatory assessments. She delivers expert consulting and testimony for medical device litigation, guiding attorneys and organizations through the complexities of the global medical device industry.
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
Medical Device Risk Management - ISO 14971
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