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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…
Process Automation, Robotic Work Cell Design, Mechanical Design, Machine & Product Design, 3D Models
Expert has been involved as lead design engineer and project manager on numerous manufacturing automation projects for more than a decade. These projects have varied from dedicated "hard automation" systems designed specifically for a single product to flexible automation cells…
Analytical Science: Elastomers, Plastics, Pharmaceutical, Medical Devices, and Transformer Oil
Expert has worked the field of analytical chemistry for over 30 years. His PhD thesis was on phosphorus NMR as a trace analytical tool. He joined Goodyear and both developed analytical methods mainly using HPLC and GC and after 6…
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…
Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for…
Biomaterials: Biocompatibility, Pathology, Devices
Expert J. Expert is a D.V.M. with a Ph.D. in veterinary pathology. He is also board certified by the American College of Veterinary Pathologists. As part of his Ph.D. research training he was involved in the characterization of several spontaneous…
Complete vertical product integration: EMC/EMI, Wireless, IoT, Audio/Video, Automotive, Imaging, Hardware, Firmware, Cloud
Expert has expertise in the design of biomedical imaging products, providing patient safety and comfort regarding ISO and FDA requirements. He is an Adjunct Professor teaching on biomedical instrumentation including cardiac, ultrasonic equipment, pressure and flow measurements. He has magnetic…
Business Plans
Array Expert has developed and implemented chemical safety procedures for several clients, including a chemical recycling facility, and metal finishers using strong acid and alkaline chemistries, etchants, and electropolishing chemicals in their manufacturing and/or wastewater treatment processes. Activities include safety…
Medical Packaging: Project Management, Design, Validation, Equipment
Expert is a certified packaging professional with over 20 years experience providing packaging engineering services to the biotechnology and medical device industries. These services include package and labeling development, packaging equipment selection and validation, and package materials and systems performance…
Medical Device Quick Prototyping/CAD Design/Concepting
Expert (pronounced "munch"; ) has designed and developed a cast base for biometric scanning. This base resulted in stable dimensions and functionality when subjected to change in temperature. Scans were used for both hand and finger use. He developed a…