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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.…
Sterilization, Sterilizers
STERILIZATION; STERILIZER; AUTOCLAVE. Expert has over twenty years of experience in the design, production, and marketing of steam and gas sterilization equipment. His experience has covered small table top sterilizers through large bulk processing units. He has been responsible for…
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…
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…
Blood Wetted Devices and Biomaterials
BLOOD-WETTED BIOMATERIAL; CARDIOVASCULAR PROSTHESES; ARTIFICIAL INTERNAL ORGANS. Expert has been involved in the design, development, and evaluation of extracorporeal and implantable artificial internal organs for many years, first with the artificial kidney (including hemodialyzers and those based upon selective absorption)…
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…
Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant to the healthcare manufacturing industries, he works with about 30 worldwide…