Find an Expert
Design & Development of Molecular IVD Assays, including Design Control, Risk Analysis, Submissions
Expert has 15 years’ work experience in the development of nucleic acid -based in vitro diagnostic (IVD) devices. He has both theoretical knowledge and hands-on experience, spanning the entire IVD pathway, which includes biomarker discovery, preclinical & clinical assay validation,…
Medical Devices; Product Development, Manufacturing, Marketing, Business Practices, Intellectual Property, Commercial Contracts, Corporate Finance, M&A
Global leader and serial entrepreneur in the medical device industry with multiple successes in building companies, teams, products, and revenues. Experienced at bringing new products to the world market in a high-growth dynamic environment. Experienced Board member and Chairman in…
Medical Devices
Expert is a medical device consultant and executive with more than 20 years experience in the medical device industry. His expertise spans all aspects of medical device commercialization, from medical device product development to medical device manufacturing and quality control;…
Accident Reconstruction, Biomechanical, Mechanical, and Neuroelectrical Medical Device Engineering.
Expert understands brain, spinal and orthopedic biomechanics and has analyzed hundreds of cases to determine the causation of injuries sustained by drivers, workers and citizens. He has performed biomechanical research using cadaveric models to understand the kinematic behavior of joints,…
Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices
Expert's firm has extensive expertise in regulatory submission. They provide different regulatory strategies to their customer’s and prepare all types of submissions on their behalf. Expert also has extensive expertise in Narcotic’s regulations. Moreover, her firm has extensive experience in…
Medical Devices, Patent Strategy, Patentability, Intellectual Property, Litigation Support
She has served as Vice President of Intellectual Property & Legal Affairs for The Sharper Image Corporation. In addition to focusing on patent strategy in several positions, she has lead and built R&D teams in both Class III medical device…
Product Development, Product Safety, Regulatory Compliance, Claims Support, Litigation Support
This expert has training and experience in the following areas: Safety of foods, cosmetics and their ingredients; and medical devices, pharmaceutical actives and excipients. Regulatory affairs related to foods, cosmetics, and medical devices. Product development of foods and cosmetics. Management…
International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance
Expert thrives on overcoming the quality and regulatory hurdles in the most time-efficient and cost-effective manner possible. He speaks fluent FDA, MDD and ISO 13485 and can converse successfully in CMDCAS, PAL, TGA, SFDA and KFDA as well. Whether you're…
Hydrogel Science and Technology for Drug Delivery, Medical Devices and Consumer Products
Expert’s major contributions are in microbial control of wide range of medical devices and pharmaceuticals. He has a background in chemical engineering and polymer science. He has decades of experience from numerous companies- large device and pharmaceutical companies to startups…
Injury Biomechanics (head and spine), Medical Device Design, Structural Analysis, Patents
Expert has over 30 years of experience in structural analysis, including experience porting finite element codes to specialized architectures, developing special-purpose mesh generation tools, and assessing the correspondence of structural models with experimental measurements. Expert has developed de novo programs…