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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…
Formulation of Fabric Conditioners, Washing Liquids and Perfume-Surfactant Interactions
Expert has applied his expertise and training in the area of intermolecular forces (vdW and London Dispersion forces) to the processing, cost and formulation optimisation/simplification and shelf-life improvement of concentrate (3x) detergent liquids and concentrate fabric conditioners over a nine…
Flexible Packaging Materials; Film Extrusion, Extrusion Lamination, Food Packaging, and Food Packaging Safety
Fellow, Society of Plastics Engineers Inductee, Packaging Hall of Fame Expert has spent over 35 years in the development and application of functional materials for a variety of packaging and non-packaging applications (process and platforms). He has developed various multi-layered…
Baking Technology, Associated Bakery Equipment (Machinery) and Dough Processing Techniques
Expert has in-depth knowledge of Baking Technology, the associated Bakery Equipment (machinery) and dough processing techniques. He has been very successful: • In operations and support of various bakery equipment, and baking technology and implementation of turn-key projects. • In…
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…
Pharmaceutical Product Development, Analytical Chemistry, Material Science, Process Development
Expert has extensive experience in pharmaceutical product development, particularly in developing drug/medical device combination products. He has over 15 years relevant experience in the pharmaceutical industry, highlighted by the launch of an anticipated $1B/year annual revenue drug/device product. Expert is…
Analysis, FEA, CFD, Medical Devices, Heat Transfer, Elastomers, Diffusion, Solar, Coupled Systems
Real invention and innovation most often springs from cross-fertilization and analogies from broad experience, quite apart from an entire career in a narrow field. See, for instance, Holyak and Thagard, "Mental Leaps: Analogy in Creative Thought". Expert is a broad…
Retail In Store Bakery, Marketing, Sales and Supply Chain; Food Service Branding, Supply Chain
Expert has over 30 years' experience selling and marketing products to retail in-store bakeries. He has had hands-on experience with doughnut, cake and dessert icings. Helping to identify, specific gravity, yield and shelf-life attributes that would enhance the value of…
Seafood Sourcing & Processing, Carbon Monoxide Seafood Treating Technologies, Fish Traps
Expert sells frozen seafood products directly and indirectly. However, ultimately the most valuable product he could sell is information. This is especially true if you are a fresh fish processor seeking to improve your product/process quality. His knowledge comes from…
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…