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Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…
Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles…
Industrial Design, Product Development, Rapid Model Making, Inventions, Prototypes, Expert Witness
Expert has been creating innovative new consumer product designs, as well as commercial, industrial, medical, toys and fitness products for over 35 years as both an Industrial Design Professional and a Creative Design Director. He has hands-on knowledge of the…
Drug Discovery & Development Technology and Intellectual Property (Patents, Trade Marks, etc.)
He has had the Drug Discovery Department, as part of his role as Director R & D, at Wockhardt Limited, discover several new NCEs during the tenure of this position, which NCEs are more extensively described in a later section…
Catalysis and Materials Characterization, Development of Biochemical Sensors, Electrode Surfaces
Expert has over thirty years of experience in both basic and applied research. His graduate work was concerned with the development of biochemical sensors based on chemically modified thermistors and electrodes using enthalpimetric and electroanalytical techniques. He also worked on…
Fashion Industry, Organizational Culture, Leadership, Marketing, Multicultural Marketing, Branding
Expert is the author of a full-length book on clothing design and the culture and organization of the fashion industry. As a Professor, she conducts research on organizational structure, culture, leadership and the creative process of design and marketing within…
Economic and Financial Analysis, Business Valuation, Economic Damages
Ph.D. and M.B.A. in finance University of Chicago Graduate School of Business. Developed Doctoral research advanced the work of three economics Nobel Laureates. Taught corporate finance in leading graduate business schools. Manager of economic analysis for the largest Federal Contract…
Electronic Enclosure Product Development Including Mechanical, Electrical, and Industrial Design
Expert has applied his mechanical engineering background to provide innovative mechanically sound solutions to difficult engineering problems. He understands the need to design for manufacturability (DFM) and design for assembly (DFA) and implements cost effective designs into each project. He…
Process Automation, Robotic Work Cell Design, Mechanical Design, Machine & Product Design, 3D Models
Expert has been involved as lead design engineer and project manager on numerous manufacturing automation projects for more than a decade. These projects have varied from dedicated "hard automation" systems designed specifically for a single product to flexible automation cells…
Biotechnology, Biochemistry, Molecular Biology: Enzymology, Protein Biochemistry, Industry
As a researcher in plant molecular biology, he published scientific data relevant for genetic modification of crops. He generated and characterized genetically modified plants, and published these data in peer-reviewed scientific journals. This research, and tangential research, allowed him to…