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Airfield Lighting, HVAC and Gas Controls, Product Development, Automotive, Appliances and Electrical Designs
Over 25 years of experiance developing, troubleshooting, cost reducing and manufacturing electronic circuits that are part of another product. This requires a vast knowledge of semiconductor components and electrical applications. Controls developed typically involved displays, electromechanical devices, sensors, relays and…
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…
Hospital Tests and Kits, Clinical Chemistry, Coagulation, Serum Controls, Manufacturing Processes
Expert received his PhD in Biochemistry (Enzyme kinetics on NAD kinase in 1981), where he proposed a mechanism, Rapid Equilibrium Random with two dead end complexes for the enzyme, using enzyme inhibition studies. He was able to apply this knowledge…
Product Design and Development; Plastic Part Design and Molding; Expert Witness, Patents
Expert has managed engineering and design consulting businesses since 1976. He has served clients in fields ranging from aerospace to sanitary services to medical monitoring and instrumentation. He has utilized his extensive experience in engineering, product development, manufacturing and aesthetics…
Medical Device Design Control and Software Validation
Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product development, design…
Regulatory Affairs/Registration Consultancy for Medical Devices/Drugs/IVDs/Food in Indian Market
Expert with a post graduate degree in Chemistry has been part of the team in the CDSCO, Government of India for framing of the Import Registration requirements for Drugs, Medical Devices and IVDs. Expert was the Medical Devices Reviewer for…
Pre-Clinical Pharmacology, Drug Discovery to IND
Expert has been a member of the Faculty of a UK university medical school for 21 years. He is Director of the Cellular and Molecular Neuropharmacology Research Group. The group’s principal research interest is 5-HT (5-hydroxytryptamine, serotonin) and has generated…
Strategic Marketing and Business Management in all Healthcare and Medical Sectors
• Successful, enthusiastic, highly motivated, strategic medical/healthcare consultant • Qualified, experienced international business manager & strategic medical marketer • Excellent track record of turning round and growing companies, products & services • Wide span of management expertise across pharmaceutical, medical…
Drug Development (Small Molecules, Peptides, Biologics, Parenteral Nanoparticles); Drug Delivery
Expert is an expert in analytical instrumentation and analytical methods development and validation, especially for drug regulatory filings with the FDA and EMEA according to all FDA and ICH guidelines. He established a state-of-art core instrument department at Altus Pharmaceuticals…