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Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…
Life Science, Biotech, Pharmaceuticals: Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization
Expert has over 20 years of experience in strategic innovation, system building, and delivering value solutions for global markets. His focus is on building infrastructure synergies between science, technology, and finance. As a Strategic Advisor, he has experience with: •…
Medical Device Technology, Design and Manufacturing
Expert is a seasoned engineer with over 25 years of expertise in all aspects of medical device research, product and process development. His major areas of expertise include minimally invasive treatments of vascular disease as well as laparascopic and open…
Pricing Models for Home Medical Equipment and Aerospace Products in the U.S.
• Pricing models for home medical equipment (beds, wheelchair, oxygen equipment, CPAP mask, humidifier, Nebulizer) and aerospace (in-flight entertainment, Broadband) products in the U.S. • Financial analysis and reports for executive decision makers. • Competitive analysis, benchmarking, cost and pricing…
Rheology, Nanotechnology, Particulate/Multiphase Processes, Chemical Engineering.
Expert operates his contract research & development small business incorporated in 1990 in Saint Paul, Minnesota, USA. Expert's professional experience spanning over four decades in chemical engineering has focused around the broad areas of particulate/multiphase processes and rheology. Chemical engineering…
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;…
Computed Tomography, X-ray Detectors, Medical Product Development, Industrial Imaging
Expert is the owner and sole proprietor of an imaging LLC. He serves as a consultant, including as a legal expert witness for topics related to X-ray imaging using Computed Tomographic (CT) methods for both Medical and Industrial Applications. He…
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…
Biostatistics Phase I, II trials, Translational research; Design, Analysis, Presentation
MD and MS in biostatistics with more than ten years of relevant professional, supervision and management experience • Experience in providing support to biomedical researchers regarding statistical aspects of study design • Expert in statistical techniques used in analysis of…