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Expert ID: 730258 California, USA

Expert 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…

Expert ID: 732460 Maryland, USA

Expert in 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…

Expert ID: 730779 New York, USA

Expert in 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…

Expert ID: 729752 New Jersey, USA

Expert in 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…

Expert ID: 728502 Massachusetts, USA

Expert in 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…

Expert ID: 727428 Massachusetts, USA

Expert in 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…

Expert ID: 725658 Texas, USA

Expert in 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…

Expert ID: 724706 New York, USA

Expert in 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…

Expert ID: 724218 California, USA

Expert in Medical Device Software, Medical Device Software Engineering, FDA Compliance, FDA 501K and PMAs for Software

Expert has wide range of extensive hands on experience developing and manufacturing medical devices. Over the last twenty plus years he has successfully deployed several medical devices in the cardiovascular, opthalmic, and diagnostic industries. His responsibilities have covered the gamut…

Expert ID: 723826 California, USA

Expert in 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…

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