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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…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Manufacturing Technologies for Pharmaceuticals, Biologicals, Biotech and Vaccines
Expert is an independent consultant to bio-pharmaceutical, medical device and vaccine manufacturers, associated equipment suppliers and investors, with over 40 years experience in aseptic process technology, new product and business development, marketing strategy and regulatory compliance for manufacturing of pharmaceuticals…
Food Safety, Food Microbiology, Foodborne pathogens, Bacteriophage therapy, Microbiology, Genomics, Whole Genome Sequencing, Diagnostic tests, Antibiotic Resistance
Expert has been formally trained in basic and food microbiology and has developed extensive expertise in this area. As a Expert, he has conducted numerous (applied microbiology) research projects that evaluated bacterial physiology under various conditions with respect to growth…
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…
Synthetic Organic Chemistry for Diagnostics, Pharma, and Biotechnology
Expert developed and successfully managed a 14-step synthetic method for a patentable alternative to a fluorescent probes. Expert has developed 4 synthetic methods for small molecule linker conjugates (with a total of 15 steps) for antibody production and synthesis that…
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…
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…