Medical Device QUALITY Expert Witness Services
Medical Device Quality and fda Regulatory COMPLIANCE
Medical device safety litigation claims may focus on the quality standards a device is developed, tested, manufactured, and deployed. Our medical device quality experts have years of experience with implementing and auditing ISO medical device standards along with FDA regulatory compliance. We have the expertise to analyze product development, manufacturing and potential risks associated with product performance and potential safety hazards.
We provide medical device expert witness services and regulatory compliance litigation support in the following areas:
SUBJECT MATTER EXPERTISE
US FDA 21 CFR
Health Canada SOR/98-282
MDSAP
EU MDR 2017/745
Risk Management Process
ISO 13485, 14971, and 9001
Quality Management Systems
Global Regulatory Analysis
Verification and Validation Process
Program Management
Clinical Evaluation and Trials
Design Development Process
Process Auditing
Post-Market Surveillance
Product Recalls and Reporting
Process Training
MEDICAL DEVICE PRODUCT EXPERTISE
Ophthalmology
Spinal Implants
Non-Active Implants
Cardiology
Ventilators
General Hospital
Orthopedics
Gynecology/Obstetrics
General Surgical Equipment
In-Vitro Diagnostics
Dental
Software
Neurology
Prosthetics
Sterilization Processes
REGULATORY AND COMPLIANCE LITIGATION
483 and Warning Letter Issuance
Consent Decree Litigation
FDA Registration and Listing Matters
FDA Approval and Clearance Disputes
MEET OUR EXPERT
DENISE HOLLIDAY
Ms. 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.
Contact Capwell Consulting for a free customized assessment of your business needs.
Denise Holliday – Medical Device Quality Expert Witness
(412) 262-9191
Inquiry@capwellconsulting.com
Denise Holliday on LinkedIn