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Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
Medical Devices, Electronic Systems, Acoustics and Hearing, Intellectual Property
Because of his long-term interest in sound and hearing, Expert has been involved with many aspects of acoustic measurement. He has developed proprietary technology for sound level measurement and noise dose determination and has utilized his skills in acoustic measurement…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
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…
Vibration Analysis, Mechanical Failure Analysis, Accident Reconstruction, Injury Biomechanics
Expert has extensive experience with the modeling and analysis of complex mechanical systems that incorporate articulated joints and that involve large and high rates of rotation. He has used angular momentum concepts to analyze the motion of falling cats as…
Electronic Enclosure Product Development Including Mechanical, Electrical, and Industrial Design
Expert has applied his mechanical engineering background to provide innovative mechanically sound solutions to difficult engineering problems. He understands the need to design for manufacturability (DFM) and design for assembly (DFA) and implements cost effective designs into each project. He…
Opto-Mechanical System Design, Performance Modeling, Electrooptics, Lasers
He has extended expertise in advanced geometrical as well as wave optics as evidenced by years of successful optical design experience using industry-standard ZEMAX and OSLO optical design packages. Expert's experience in biomedical imaging is based on two years of…
Patent & Copyright Infringement, Depositions & Testify, Cell Phone Tracking, GPS, Cell Tower Records
Expert has consulted for law firms in California in connection with helping them write claims that provide the best patent coverage. He helps them in avoiding infringement by devising different technical approaches and novel ways to patent ideas and designs.…
Machine Vision, Sensors, Analog & Digital Design, Communications
The circuit design approach that the expert uses begins with a system level point of view. He develops a detailed specification for circuit requirements in the context of the over all product. This allows him to optimize its partition among…
Medical Device Design and Manufacture
Expert has over 25 years experience in the conception, design, and manufacture of medical devices. Experience ranges from high volume disposables to low volume implantables. Beginning as a manufacturing engineer responsible for all facets of device development and manufacture Expert…