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biocompatibility testing

evaluation

testing

product evaluation

cytotoxicity testing

medical device coating material

medical device clinical research

medical device endotoxin detection

biocompatibility

medical device manufacturing

medical device

FDA medical device regulation

biocompatible material

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 Medical Device Technology, Molecular Biology, Virology, Infectious Diseases, Tissue Engineering
Expert is a Clinical Trials manager in the National Health Service, UK; where she is involved in Stroke trials. She has had significant experience in the area of Tissue engineering and Stem cell biology for the last 5 1/2 years where she worked as a ... See full profile

United Kingdom

Expert in Biomaterials, Intraocular Lens Implants, DNA Analysis
Expert has completed doctoral studies in developing a novel polymer for intraocular lens implants. During this study she has designed several new experimental methods to detect polymer biocompatibility and toxicity to ocular and other cell types. See full profile

Ontario, Canada

Expert in Biomaterials, Drug Delivery, Tissue Engineering, and Regenerative Medicine
Expert is an internationally recognized expert in biomaterials development, drug delivery (e.g., protein, plasmid DNA, etc), tissue engineering, and regenerative medicine. Expert, PhD, received his B.S.E. in Mechanical Engineering and Material Science and ... See full profile

Ohio (OH), USA

Expert in Biological Responses to Medical Device Materials and Coatings
Expert was responsible for the development of a novel, biocompatible, bioactive, bone-like bone cement, suitable for usage in craniofacial applications. Expert completed his PhD in Medical Materials Engineering at Kings College University of London in May of ... See full profile

United Kingdom

Expert in Hydrogel Science and Technology for Drug Delivery, Medical Devices and Consumer Products
Expert's major contributions are in microbial control of wide range of medical devices and pharmaceuticals. He has a background in chemical engineering and polymer science. He has decades of experience from numerous companies- large device and ... See full profile

New York (NY), USA

Expert in Cardiac Surgery, Heart Transplant, Coronary Artery Bypass, Valves, atrial fibrillation, LVAD
Expert is a cardiothoracic surgeon. He has expertise in coronary artery bypass grafting (CABG), mitral valve repair/replacement, aortic valve replacement, aortic aneurysm repair, surgical treatment of heart failure with cardiac transplantation and ... See full profile

Michigan (MI), 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 QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing
Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. See full profile

California (CA), USA

Expert in Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination ... See full profile

Minnesota (MN), USA

Expert in Adhesives, Polymer Nanocomposites, Plastics, Biomaterials
Expert wrote his Ph.D. research in the area of thermosetting composite and rubbery materials. After graduation he began work with National Starch and Chemical Company in specialty pressure-sensitive adhesives and moved then to Integra Life ... See full profile

Pennsylvania (PA), USA

Expert in Medical Devices, Biomaterials, Due Diligence, Business Development
Expert has extensive research and development expertise having spent over 20 years in the development of orthopaedic implants. This lead to over $1billion in sales. The technologies developed included calcium phosphate cement, 2 different calcium phosphate ... See full profile

New Jersey (NJ), USA

Expert in Clinical Trials, Drug Development, Medical Monitoring, AIDS, FDA Regulation, Safety Assessment
Expert is a public health professional who has extensive international and domestic experience. She has worked for pharmaceutical/biotech companies, hospitals, public health institutions, non-profit organizations, in the areas of clinical trials ... See full profile

California (CA), USA

Expert in Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and ... See full profile

Illinois (IL), USA

Expert in Biodegradable Systems for Controlled-Release Drug Delivery
Expert has a D.Sc. in bioorganic chemistry, a Ph.D. in polymer chemistry and over 25 years of experience in analytical and physical chemistry of biopolymers. In a very recent assignment Expert has established and directed an analytical chemistry ... 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 Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new ... See full profile

Florida (FL), USA

Expert in Medical Device Manufacturing & Biocompatible Material: Orthopaedic Devices, Cardiology, Review, etc.
Expert has been actively involved in orthopaedic, cardiology and urology development projects for a number of years. All of these projects have relied upon and require biocompatible materials. As such he has developed an excellent understanding of the ... See full profile

NJ, Israel

Expert in Medical Device Product Development; Machine Design; Biomedical Engineering
Medical device product development engineer. He performed research on adding an antimicrobial agent to a silicone rubber medical device molded using LIM. Research included materials, methods of molding, color changes, and effect to biocompatibility. See full profile

New Hampshire (NH), 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 Medical Device: Design, Development, Manufacturing and Quality Assurance
He has been involved in Good Manufacturing Practices (GMP) for over twenty seven years in Class II and III product environment. Set up and maintained Class 100,000 clean rooms and manufactured Class II Critical and Class III devices in this environment. See full profile

New York (NY), USA

Expert in Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into ... See full profile

Delaware (DE), USA

Expert in Skin Care, Dermatologic Products and Cosmetics, Cosmetic Skin Surgery
As a board certified dermatologist involved in clinical care for the past 25 years, and an Associate Clinical Professor of Dermatology at Mount Sinai School of Medicine, and an author of numerous books, by-line articles, and audiotapes on skin care and ... See full profile

New York (NY), USA

Expert in Membranes, Filters, Separations, Validation, Extractables, Leachables
Expert was responsible for building a new manufacturing facility for hollow-fiber thin film composite membranes for industrial gas and liquid. He helped design the equipment, created the plant layout, hired staff, and led the trouble-shooting phase. See full profile

Oregon (OR), USA

Expert in Medical Device Design and Manufacturing: Laboratory Devices, Surgical Instruments, and Disposables
Expert has expertise in the design and development of laboratory devices, surgical instruments, and disposables for the biotechnology, pharmaceutical, medical device, electronic, cosmetic, and consumer product industries. See full profile

California (CA), USA