Expert Directory
Having an expert witness or consultant at your side can help you navigate complex situations with confidence. These professionals understand your industry and excel at conveying crucial information, whether in a courtroom or a consulting environment. At Intellex, we have experts in over 30,000 areas in our database. We enable you to partner with an individual who has the knowledge, educational background, and relevant experience to support your needs effectively.
Utilize our expert finder tool to handpick the ideal mentor or consultant for your specific application.
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…
Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
Near-Infrared Spectroscopy, Statistics, Chemometrics, and Software Development
Expert has expertise in the design and development of spectroscopic instrumentation, particularly in the near-infrared spectral region. He was on the design team for several of the instruments produced by a major manufacturer. He was the chief system troubleshooter, integrating…
Software Process Standards
Expert is considered an expert on the standards required to write software for the Web. He recently co-authored the book: A Guide to Standards and Specifications for Designing Web Software. He has published three books on software engineering standards and…
Manufacturing, Project Management
Expert (pronounced ko-val-ski, ) has conducted seminars and instructed consultants on how to utilize state-of-the-art project management techniques. He can develop project plans and evaluate project management software and techniques. He can assist or critique how to set up, schedule,…
Automated Chemical Sensors
LABORATORY COMPUTERIZED ANALYTICAL INSTRUMENTATION DESIGN; CHEMICAL AUTOANALYSIS. Expert has spent much of his career developing systems or subsystems for devices accomplishing automated chemical analysis. He has experience in all phases of this process, from basic research into sensors to the…
Process Control, Systems, and Optimization
Most recently Expert’s work has centered on pharmaceutical batch processes requiring Food and Drug Administration (FDA) software and hardware validation. Expert notes that generally, this requires a data model (both procedural and physical) following the guidelines of ANSI/ISA S88.00.02 and…
Biomedical Device Engineering
BIOMEDICAL PRODUCT DEVELOPMENT; MEDICAL DEVICE PRODUCT DEVELOPMENT; NEW PRODUCT DEVELOPMENT. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. Expert has directed medical device new product development projects and a product…
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…