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Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Systems Engineering, Project Management, Programme Management, Software Development
Expert has applied his systems engineering expertise in a wide range of information systems in the aerospace, defence and transportation sectors. He has developed and deployed innovative systems engineering processes and used these on many of the projects and systems…
Lost Sales, Damages, Consumer Goods, Patent & IP litigation, Product Defects, Forensic Investigation
Expert holds 62 patents. He has created over 200 products and has directed manufacturing, sales and distribution world-wide. He has 30 years' expertise in design, defects, sales, lost sales, IP infringement, unfair competition, validity, reasonable royalties, contracts and many other…
Scientific Research: Instrument Design, Survey Research and Analysis, Program Evaluation, Reports
She is an expert in research methodology and statistical analysis. She designs and directs all phases of survey research -- sampling, user-friendly instrument design, interviewer training, data collection, data cleaning, statistical analysis, and interpretation and presentation of resarch results with…
Mathematics, Navigation System Design & Data Analysis, Airspace Collision Risk & Safety Analysis
Expert has been working through the period of development of satellite based navigation systems. He has been intimately involved in the development of techniques to improve accuracy, reliability, and availability of such systems including the development of a Mathematical Model…
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: •…
Mechanical Properties, Materials Science, Polymer Science, Fracture, Failure Analysis
Expert has worked in this field for 30 years. His PhD concerned discontinuous fibre composite properties and fracture behaviour. He has published extensively in this area. He worked in research, production, product development and management in the chemical industry -…
Computational Electromagnetic Modelling and EMC, Signal & Power Integrity, Remote Sensing, Microwave
Expert worked as research manager (5 years) and principal scientist (2 years) at Nokia for 10 years. His research managerial tasks include line (resource) management, conducting internal research projects, university & EU (European Union) projects co-ordination, and preparing EMC research…
Odor Control Chemistry and Application Equipment for many Segmented Markets
Expert built a specialty chemical and engineered application manufacturing company from concept in environmental air odor management. The firm grew from concept (start-up) to market branding in North America, and portions of Europe. The firm evaluated nuisance odors in emission…
Plumbing System Design; Water Fittings Design; UK Water Regulations; Legionella
Expert has been involved for in Expert Witness work for 30 years. He has been a member of the U.K National Expert Witness Agency. He is a long-standing Member and a Fellow of the Chartered Institute of Plumbing and Heating…