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Expert in FDA Regulatory Consultant for Medical Devices, Cosmetics, and OTC Drugs
Expert is a renowned authority in the cosmetic, OTC drug and medical device industries. He has had over 40 years of experience dealing with regulatory, scientific, and technical issues for FDA regulated industries. He served as Senior Vice ... See full profile

Maryland (MD), USA

Expert in Medical Device, Biotech, Pharma R&D, Tech Transfer, Mfg, Compliance, IP Valuation, Process Improvement
Expert has an impressive and verifiable record of significant product, process and business improvements since 1980. These include: Time to market, new product development system improvement; Reengineering; Business unit performance and profitability ... See full profile

New Jersey (NJ), USA

Expert in 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, ... See full profile

California (CA), USA

Expert in Technology Transfer, Technology Forecasting and Innovation, Mobile Application R&D, Wearable Systems
Expert has over 20 years of developing or leading the development of application software for both personal computers and mobile devices. He is experienced in Java, C, Smalltalk, and C++. Object Oriented Analysis, Design, and Development were used in all ... See full profile

Illinois (IL), USA

Expert in Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants
Expert has helped assemble, and been lead author on 510(k) and IDE applications to the FDA. This has often included telephone conversations, and occasionally personal visits, with the FDA to discuss unique aspects of the devices ... See full profile

Ohio (OH), USA

Expert in Plastics Processes: Extrusion, Injection Molding, Blow Molding, Structural Foam Molding, and Training
Expert has over 50 years of plastics processing experience with the main focus on extrusion processes using extruders, twin or single screw, for compounding, film, sheet, profile. He has extensive experience with feed screw design and die designs. See full profile

Ohio (OH), USA

Expert in Neurotechnology, Brain-Computer Interfaces, Neurological and Neurosurgical Medical Devices
Expert, MD, PhD, is a Neurologist and Translational Neuroscientist at Expert's Consulting Firm since July 2011. He was a Neurologist and Translational Neuroscientist at the University of Pennsylvania, a position he has held from July 2010 to ... See full profile

Pennsylvania (PA), USA

Expert in Pharmaceutical Product Development, Drug & Medical Device Safety, Regulatory Affairs
Expert is active in U.K. General Practice with wide therapeutic area knowledge and practical patient prescribing. He has a good understanding of the U.K. health system, formulary adoption, N.I.C.E., and reimbursement. See full profile

Berkshire, United Kingdom

Expert in 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. See full profile

Connecticut (CT), USA

Expert in Oil and Gas, Drilling, Offshore
Expert has approximately 20 years of offshore drilling project management, contracts, engineering, sales and strategy experience. After graduating from Texas A&M Galveston in 1996 with a B.S. in Maritime Systems Engineering, Expert was employed with Waller ... See full profile

Texas (TX), USA

Expert in Product Development and Regulatory Approval of In-Vitro Diagnostics and Companion Diagnostics
PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and ... See full profile

California (CA), USA

Expert in Real-Time Embedded Control Software
Experience and expertise is in real-time embedded software and its development, IP, training and support. Having experience working with small to mid-sized companies in communications, automation, consumer electronics and automotive industries, Expert ... See full profile

Michigan (MI), USA

Expert in Medical Devices
Expert is a medical device consultant and executive with more than 20 years experience in the medical device industry. His expertise spans all aspects of medical device commercialization, from medical device product development to medical device ... See full profile

California (CA), USA

Expert in Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems ... See full profile

California (CA), USA

Expert in Computers, Software, Hard Disk, Bus, Internet, Firmware, Input/Output, Technology Management
Expert is a technical leader in the computer, software and hard disk industry with over thirty years experience; his Ph.D. in Computer Science is from Stanford University. He is an inventor on seven patents and has authored several published technical ... See full profile

California (CA), USA

Expert in 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 ... See full profile

Virginia (VA), USA

Expert in Product Approval and GMP Compliance to Medical Device Regulations
As compliance officer with the CDRH's Office of Compliance, expert was responsible for evaluating results of foreign and domestic inspections conducted by the agency based on current Good Manufacturing Practice Regulations. His experience with the FDA has ... See full profile

Virginia (VA), USA

Expert in Design & Development of Molecular IVD Assays, including Design Control, Risk Analysis, Submissions
Expert has 15 years' work experience in the development of nucleic acid -based in vitro diagnostic (IVD) devices. He has both theoretical knowledge and hands-on experience, spanning the entire IVD pathway, which includes biomarker discovery, ... See full profile

Washington (WA), USA

Expert in Accident Reconstruction, Biomechanical, Mechanical, and Neuroelectrical Medical Device Engineering.
Expert understands brain, spinal and orthopedic biomechanics and has analyzed hundreds of cases to determine the causation of injuries sustained by drivers, workers and citizens. He has performed biomechanical research using cadaveric models to ... See full profile

Texas (TX), USA

Expert in Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain
Experienced global leader of R&D, Technical Operations, and Manufacturing organizations. Industrial focus in Medical Devices, Small Molecule Pharmaceuticals, Biotech, Packaging/Labeling, and Combination Products. Broad functional experience in the fields ... See full profile

Massachusetts (MA), USA

Expert in Mobile Cellular Telecommunications Handset, BTS, TRX and EnodeB Development (GSM 2G, GPRS, EDGE, UMTS 3G, LTE 4G, LTE-A); 3GPP ETSI Protocols [NAS/AS]; Software, Systems and Standards; IPv6, M2M (IoT)
Expert is a professionally registered chartered engineer and a senior member of the IEEE, with extensive software and systems development experience (solutions provider). His strengths are his innovation, pragmatic approach, reliable delivery and ability ... See full profile

Berkshire, United Kingdom

Expert in Microsoft Server Administration, VMWare, Exchange, Clustering, Networking and Active Directory
Expert (MCSA+M, MCP, CCNA, A+, Network+, Net+, MCTS:Exchange 2007) is a Senior Microsoft Systems Engineer with 12 years of experience in IT. His specialties include Windows Server 2000\2003\2008, Exchange 2000\2003\2007, Active Directory, ... See full profile

Minnesota (MN), USA

Expert in Medical Device Design and Manufacture
Expert has over 25 years experience in the conception, design, and manufacture of medical devices. Experience ranges from high volume disposables to low volume implantables. Beginning as a manufacturing engineer responsible for all facets of device ... See full profile

Minnesota (MN), USA

Expert in Embedded Linux, Microcontroller Firmware, and Real-Time Operating Systems
Expert has been designing and writing computer software for over 30 years. He has programmed in C, Pascal, Fortran and assembly language. His primary emphasis is on applications related to data acquisition, instrumentation and embedded ... See full profile

New Mexico (NM), USA

Expert in Animal Models, Preclinical Testing, GLPs, Protocols, Data Capture Forms, Veterinary Medicine
Expert has a significant amount of experience with developing animal models through discussions with cross-functional groups and considerable expertise in veterinary surgery and biomechanics. He has experience with animal models for the cardiovascular, ... See full profile

Michigan (MI), USA

 
 

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