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Environmental and Occupational Health and Safety
Expert is an experienced Occupational Safety and Health professional with over 30 years of diverse background as a trainer, consultant, and manager. Currently a high-level team leader with highly effective interpersonal and communication skills, Expert is recognized as an organized,…
Medical Device Development
BSME - Mechanical Engineer: 40+ years Medical Device design & development (13 patents) - Drug delivery devices, respiratory care devices, hemodialysis, and blood collection devices, in-vitro diagnostic instrument, and cartridge devices; 25+ years medical device product liability and patent infringement…
Geostatistics, Multivariate Statistics, Site Characterization, Uncertainty Modeling, Sampling Design
Expert has 20 year experience in the geostatistical analysis of environmental data and health outcomes. He has more than 140 referred publications in the field of theoretical and applied geostatistics, including the 4th most highly cited textbook in geostatistics, totaling…
Resolving Simple and Complex Antibody Problems, Blood Banking and Transfusion
Mrs. Expert has worked in the area of transfusion medicine and blood banking as a"Blood Bank Specialist" for 25 plus years. During that period, she has managed a donor service, done alot in the area of training and teaching and…
Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Medical Device Software, Safety Critical Systems, Embedded Systems Design
Expert managed the Electrical Engineering department of a consulting company specializing in medical device design. He has designed software, firmware and hardware for medical devices including a Proton Beam Radiotherapy system, blood infusion pumps, blood analyzers, hysterscopic pump, drug scanning…
Retail Industry Safety & Health, Environmental, Solar & Renewable Energy
Expert has performed Expert Witness consulting work in Retail Safety, Slip/Fall Floor Safety, Food Safety and Premises Liability. He has extensive experience as an Expert Witness in the Legal Arena as well as experience with government agency compliance issues working…
Strategy and Sales Analysis for In Vitro Diagnostics and Biopharmaceuticals
Expert has multiple experiences in evaluating and proposing strategy for brands or individual products. This list includes several existing diagnostic products where lifecycle planning needs require judicious selection of new and novel add-ons to an existing line. It also includes…
Medical Device Design and Analysis
He was responsible for providing product data for 510(k) submittals. He was responsible for developing devices and technology for patient gas monitoring devices, cardiac monitoring devices etc. He was responsible for the development of several defibrillators. He was responsible for…
Biotechnology, Enzymes, Environmental Bioremediation, Regulatory Compliance
Expert has over 40 years of experience in both basic and applied Biochemistry (biochemical research and enzymology) and Biotechnology. He is very successful in finding flaws in published and spoken materials. His strengths are in the fields of physical biochemistry,…