Design Controls Expert Witnesses

Westminster, Colorado

Medical Devices, Biomedical Engineering - Medical device, Biologics, Manufacturing, Risk Management, Design History File, FMEA, Stem Cells, Biomaterials, Product Liability, Intellectual Property, Implant, Collagen, Device testing, Design Controls, Product labeling, CDMO, Quality/Regulatory, Allograft, Forensic Science

10+ years in medical device/biologics design, development, and manufacture 15 years in design and operational engineering Inventor on two biomedical patents Qualified Nuclear Engineering Officer in the US Navy First author for 3 peer-reviewed original scientific research articles

Santa fe, New Mexico

Medical Devices - Medical Device Regulatory Compliance, Quality Management Systems, Design Controls, Risk Management, Implantable Medical Devices, Medical Device Product Liability

Anne Holland is a medical device regulatory compliance, quality systems, and design controls testifying expert with more than 35 years of experience in the medical device industry. Her expertise includes FDA Quality System Regulation (21 CFR Part 820), ISO 13485, MDSAP, EU MDR, design controls, risk management, CAPA, complaint handling, adverse event investigations, supplier quality, auditing, and post-market surveillance. She has held executive leadership positions and founded QA Consulting, Inc., which has provided quality and regulatory consulting services to hundreds of medical device manufacturers. Ms. Holland has substantial experience as a testifying expert in medical device product liability litigation, including U.S. multidistrict litigation and Australian Federal Court proceedings involving implantable medical devices. Her expert witness experience includes two trial testimonies, eight depositions, fourteen expert reports, and multiple forensic consulting engagements invo...