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Cleanroom Technology
Expert has applied his background in the clean room industry to help those clients who are considering the use of clean rooms for their manufacturing process. He can assist with material alternatives and equipment selection that best fits into a…
Microcontroller-based Product Design
Most of the projects expert has been involved with have been real-time dependent. He has designed high-speed bit-slice-based data acquisition units for military aircraft radar, high-speed machinery controls, home automation, cordless telephones, fitness equipment, arcade games, and other consumer products.…
Plastic Molding Processes
Expert has extensive experience with plastic molding processes and with injection molding in particular. He is often called upon to help clients with issues such as injection molding machine selection, injection mold lubrication, and in-mold labeling. He has been responsible…
Package Development and Testing
Expert has over 25 years experience with the development, engineering, and troubleshooting associated with a variety of packages. She has developed and selected materials and components involving rigid plastics, cartons, and flexible packaging. She has designed and prepared specifications and…
Animal Models, Preclinical Testing, GLPs, Protocols, Data Capture Forms, Veterinary Medicine
Expert has a significant amount of experience with developing animal models through discussions with cross-functional groups and considerable expertise in veterinary surgery and biomechanics. He has experience with animal models for the cardiovascular, peritoneal, gastrointestinal, cutaneous, reproductive, urinary, and skeletal…
CAD/CAM
Throughout his professional career Expert has both been a member and an active contributor to several professional associations, beginning in 1962 with a student membership in the Society of Manufacturing Engineers (SME). He also became a member of the Computer…
Sterilization, Biomaterials, Tissue Banking, Medical Product Development, Polymer Toxicology
Expert K. Expert has spent 30 years in the medical products business, in which he developed sterilization processes such as ethylene oxide, gamma radiation, vapor phase hydrogen peroxide, plasma sterilization, aseptic processing, disinfection with formaldehyde, glutaraldehyde, and steam sterilization. Novel…
Medical Device Total Quality
FDA REGULATION. A significant portion of Expert's career has been devoted to FDA approval and regulation of medical devices, particularily those with significant risk. He is the President of a consulting company specializing in process validation, FDA/regulatory consulting, and auditing.…
Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…
Materials Processing
SIZE REDUCTION OF SOLIDS; GRINDING (COMMINUTION). Expert (prefers "Expert") has spent a significant portion of his career in size reduction technology, chiefly involving himself with the identification, selection, and qualification of crushing, grinding, and milling processes. He has developed processes…