Find an Expert
Medical Devices, In Vitro Diagnostics Design, Quality Control, Trouble-Shooting, etc.
Expert has authored and submitted 510(Experts for more than 25 IVD (In Vitro Diagnostics) products. These 510(Experts encompass a variety of IVD products from manual, semi-automated to fully automated non-isotopic diagnostic tests including point-of-care devices. Expert has the expertise to…
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…
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…
Plastics and Medical Device Development, Plastics Processing, Material, Tooling, Failure Analysis
Expert is a huge proponent of concurrent engineering practices. He has helped numerous companies by helping them implement principles of concurrent engineering which requires all the departments from marketing to manufacturing and assembly to work together right from the inception…
Resistance Welding, Laser Welding, Arc Welding, Ultrasonic Welding, Brazing, and Soldering
He has extensive experience in brazing starting with his PhD (Penn State) in brazing of structural ceramics. He worked on the Alumnia-Titanium system using an active braze alloy of Ag-Cu-Ti composition. Active brazing has found wide acceptance in brazing of…
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…
Product Development, Product Design, Project Management
Expert has been directly involved in the development of medical devices and their manufacturing processes for nearly forty years. These included ten years of responsible positions in industry, as well 30 years as the president of medical device product development…
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…
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…
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…