Medical Device Regulatory Compliance Expert Witnesses
Medical device regulatory compliance expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on medical device regulatory compliance. The medical device regulatory compliance expert witness listings on this page are typically from fields/areas of expertise such as: Medical Devices.
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Anne K Holland
Medical Device Regulatory Expert
Anne Holland Consulting, LLC
Santa fe, New Mexico
Medical Devices
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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...
