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Medical Device Software, Safety Critical Systems, Embedded Systems Design
Expert managed the Electrical Engineering department of a consulting company specializing in medical device design. He has designed software, firmware and hardware for medical devices including a Proton Beam Radiotherapy system, blood infusion pumps, blood analyzers, hysterscopic pump, drug scanning…
FDA Regulatory Expert Witness Regarding Medical Devices, Drugs, Software and Data Integrity
Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. Talented in depositions and testimony. Specialist in analyzing drug/medical device-related safety data and FDA compliance information to answer three questions: 1) What did the…
Artificial Intelligence, Biomedical devices, Telecommunications devices and protocols, Software Development, Software Testing
Expert worked as a distinguished member of technical staff at Bell Labs in the field of test generation for complex systems. He has seven U.S. patents in the fields of testing and artificial intelligence. He co-haired several international conferences in…
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…
Medical Device Design Control and Software Validation
Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product development, design…
Intellectual Property Transactions,Technology Transfer, Licensing, Software, Medical Devices
Expert is a C-level Business Executive with expertise in high-value/risk intellectual property (IP) transactions; technology transfer and licensing; medical devices and related technologies, software and hardware engineering development. She has extensive experience through full lifecycle program management and product rollout…
Human Factors Engineering for Medical Devices and Software, Patient Safety
Expert has a PhD in Computer and Information Science with a major in artificial intelligence and minors in the theory of computation and cognitive science. His artificial intelligence worked included knowledge sharing and problem solving strategies for knowledge-based systems ranging…
Otolaryngology: Surgery & Management; Medical Device and Software Design- Lasers & Robotics
Expert P. Expert, MD is currently Director of Otolaryngology & Communicative Disorders at North Shore University Hospital, a component of the North Shore - Long Island Jewish Medical Center. He is also a Director and Founder of the Laboratory of…
Electronics, Software, Sensors, Motion Control, Wireless, and Medical Devices
Expert and his senior team have many years of experience designing embedded circuits, instruments, medical devices, and software. Expert in all types of measurements. Analog circuit design, digital circuit design, and mixed signal design, as well as measurement and control…
Metal Forming
Expert is an experienced court-recognized testifying expert witness for metal fabrication and stamping litigation. He has published 88 technical articles for leading trade magazines. He possesses direct, hands-on, cradle-to-grave experience with progressive, transfer, and tandem stamping dies for Class A…