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Medical Device Design and Analysis
He was responsible for providing product data for 510(k) submittals. He was responsible for developing devices and technology for patient gas monitoring devices, cardiac monitoring devices etc. He was responsible for the development of several defibrillators. He was responsible for…
Biomedical Engineering, Patents, Medical Device Design, Product Development, Eye Activity Devices
He has served as a consultant as well as trained and led numbers of team consultants in application software development projects for over 20 years. Masters Degree specializes in optics and diagnostic/remediative processes and devices based on eye activity. PhD…
Development and Assurance of High-Assurance / Safety-Critical Software & Embedded Systems
Expert has substantial experience with software safety and reliability. Most of his career has been spent working with high-assurance systems and safety-critical software. He has developed software for commercial aviation systems, for medical devices, and for industrial controls and safety…
Software Development, Technical Writing, and Project Management
Expert has experience with Software development tools for embedded systems engineers, marketing, project management, and technical publishing. The technical publications Expert develops show three essential qualities: close attention to the needs of the audience, correct content, and a clean look…
Process Automation: Process Control, Computer System Validation, Alarm Management, & Modeling
Expert served for several years as a major pharmaceutical company's chief Quality Assurance GMP/GLP computer validation auditor. He chaired the team that developed the company's first policy and guidelines regarding computer validation,- and served for several years as the company's…
Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals
Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO. In addition to filing and prosecuting patents, he also has experience…
Software and Internet Business and Technology Development
He has worked in the field of artificial intelligence since 1971. In automated planning and problem solving, he developed highly efficient methods for state-based search, and invented what is now termed “modern” or “partial-order” problem solving. He conceived of and…
Healthcare Consulting: Strategic Planning, Product Development, and Product Launch
Expert has been providing expert strategic and operational advisory services to healthcare investors and development stage healthcare companies for nearly 10 years. He has been involved in direct healthcare management for over 15 years, and has been practicing medicine since…
Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Management, New Product Development, and Plant Relocation and Startup
As part of top management's efforts to maximize revenue, growth and profitability, Expert has applied over 35 years of business, engineering and manufacturing expertise to provide cost effective solutions across a wide-range of industries. Expert maintains that it all starts…