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Clinical Nursing-Adult Health
Expert has been an RN for 23 years. Her clinical back ground is telemetry, ICU, med/surg. Expert was a clinical educator and also taught at a university. Expert is currently the Chief Nurse for Specialties; She has oversight of nursing…
Franchising, Licensing, Dealership, Distributorship and Affiliate Chain Distribution Channels — Domestic and International
Expert is Managing Partner of an eponymous consulting group. He has 40 years of experience within the franchising industry in various capacities as a franchisee, franchisor and a franchise advisor to private and public companies operating in the United States…
Clinical Laboratory Science, Lab Directing, Lab Diagnostics, Medical Technology, Hospitals, Testing
Expert is a clinical laboratory scientist with 30 years of experience in the industry covering laboratories in the hospital, national reference, and large physician office settings. He is the founder of a consulting company which began in 2009. The company's…
Instrument Design and Development; Medical Devices, In-vitro Diagnostic Instruments; Clinical Laboratory Automation; Project Management; Planning, Scheduling, Budgeting. QSR and Design Control
Expert possesses a 30-plus-year track record managing medical device and in-vitro diagnostics development from concept to successful market introduction. A proven manager, he has accrued significant skills in leading diverse and multi-organizational teams in the successful development of leading edge,…
IVD Assays and Diagnostic Tests Development
Expert's areas of expertise include the following: IVD (in vitro diagnostics) clinical laboratory regulation molecular diagnostics blood assay diagnostic instrumentation assay development CLIA-88 (Clinical Laboratory Improvement Amendments of 1988) clinical laboratory regulation quantitative risk analysis (risk assessment) laboratory management GLP…
Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Intellectual Property, Patents, and Medical Devices
Expert is an award-winning, Oxford-educated scientist with expertise in electronics, medical imaging, medical devices, sensors, semiconductors, MEMS, image processing, and signal processing. He has been deposed in a patent case. His experience spans a variety of industries and applications, including…
Quality Assurance, Regulatory Affairs, and New Product Development Consultant
BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…
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…
In Vitro Diagnostics Industry Including Clinical Laboratory, Immunohematology & Donor Screening
Expert's 40+ year career has spanned a variety of business disciplines and functions including information management, supply chain management, customer service, new product development, sales, and new business start-up. He began his career at Eastman Kodak Company as a Systems…