Medical Devices Expert Witnesses in New York

Biomedical Engineering, 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 13 companies, and is currently serving as a member of the Board of three companies. 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...

New York City , New York

Medical Devices, Pharmaceutical Regulation - Medical Device FDA Regulation, Biologics FDA Regulation, FDA Compliance, FDA Warning & Labels, Product Liability, FDA Regulations, Medical Device Product Liability, Clinical Trials FDA Regulation, Medical Device FDA Approvals-Clearance, Medical Device Recalls, Medical Device Complaints, Biomedical Engineering

Dr. Ediuska Laurens is a highly credentialed biomedical engineer and expert in FDA regulation, compliance, and product liability for medical devices and biologics. She provides expert witness services to both plaintiff and defense counsel in litigation involving medical device and biologics FDA approval and clearance, labeling and warnings, quality systems, adverse event reporting, clinical trials, and post-market surveillance. Dr. Laurens brings over 20 years of combined industry, research, and regulatory experience. She has led regulatory and quality efforts across the entire medical device lifecycle, from concept through commercialization, supporting product development, regulatory submissions, and quality compliance for a wide range of technologies, including cranial and orthopedic implants, spinal and neural devices, tissue engineered-biologics and combination products, hydrogel biomaterials, as well as pediatric and women’s health innovations, among others. Attorneys rely on...