Anne Holland

Principal, Anne Holland Consulting

Anne Holland is a biomedical engineer with more than 35 years of experience guiding regulatory, quality systems, and design control programs for medical device manufacturers across the U.S., Asia, Europe, and Australia. As Founder and CEO of QA Consulting, Inc., she has advised more than 400 device manufacturers — from heart valves and spinal implants to total joints and muscle stimulators — and has personally conducted more than 100 supply chain and internal quality audits.

Since 2005, Anne has applied that same technical depth to litigation. She has served as a testifying expert in U.S. multidistrict litigation and an Australian Federal Court proceeding, with experience spanning two trial testimonies, eight depositions, and thirteen expert reports. Her casework has covered pelvic mesh, hernia mesh, orthopedic implants, and other Class III and implantable devices, with a focus on FDA Quality System Regulation (21 CFR Part 820), ISO 13485, MDSAP, EU MDR/IVDR, design controls, risk management, CAPA, and complaint handling.

Anne is retained by both plaintiff and defense counsel, and holds current certifications including EU MDR Auditor, MDSAP Auditor, IVDR (2026), Quality Management System Lead Auditor, RQAP-GLP, and ASQ Certified Quality Engineer, Auditor, and Manager of Quality/Organizational Excellence.