Medical Devices Expert Witnesses in New Mexico

Medical Devices, Intellectual Property - Medical devices, commercially reasonable efforts, patent, intellectual property, product liability, corporate governance, licensing, strategy, inter partes review, misappropriation of trade secrets, ITC, IPR, ITC, fiduciary duty, pacemaker, defibrillator, neurostimulator, biomedical engineering

Peter Crosby is a biomedical engineer with over 45 years experience in the medical device industry, and has served as CEO of six medical device companies, public and private, in 4 countries. He has served as a member of the Board of 14 companies, and is currently serving as a member of the Board of fourcompanies. He has brought many medical devices from concept to market release, through R&D, clinical trials, regulatory approval (FDA and CE Mark) and market launch. He is an inventor of over 50 issued US patents and applications and foreign equivalents. He has served as an expert in multiple patent cases - infringement, ownership, validity, IPR and ITC. His clinical domain and specialty experience includes otolaryngology, cardiology, cardiac surgery, anesthesia, pain management, radiology and diagnostic imaging, in vitro diagnostic devices, orthopedic surgery devices, and oncology. His product experience includes cochlear implants, diagnostic ultrasound, mammography, implantable c...

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...