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Expert Quote | | |  | | 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 FDA Medical Device Regulation, Expert Testimony
Expert initiately was a FDA field office investigator (drug manufacturing specialist) and compliance officer in the then FDA Bureau of Drugs. During his 17-year career in the FDA Center for Devices and Radiological Health Expert helped to initiate ... See full profile | | North Carolina (NC), USA | | | |  | | Expert in Medical Devices and Diagnostics; Life Sciences Products Development, Manufacturing, Marketing
Expert has been the CEO of 6 medical device companies in three countries - 3 public, 3 private, and has been a member of the Board of Directors of seven companies. He is an expert in all areas of general and specific management of a medical device or ... See full profile | | Minnesota (MN), USA | | | |  | | Expert in FDA Regulations, Labeling and Compliance; Medical Devices, Medical Products Liability
Expert has over 35 years medical device industry experience actively involved in the design, development, manufacture, FDA regulation compliance, labeling, and quality control of medical devices. His expertise includes implementation of corporate ... See full profile | | Minnesota (MN), USA | | | |  | | Expert in Medical Device Technology, Design and Manufacturing
Expert is a seasoned engineer with over 20 years of expertise in all aspects of medical device research, product and process development. His major areas of expertise include minimally invasive treatments of vascular disease as well as laparascopic and ... See full profile | | California (CA), USA | | | |  | | Expert in Semiconductor fabrication, packaging, laser processing, Reliability, fuse redundancy
Expert has his doctorate from the world's top research university with over 20 years experience in semiconductor device fabrication and manufacturing. He has several patents related to laser processing of application specific circuitry and ... See full profile | | Israel | | | |  | | 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 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 Implantable and Non-Implantable Medical Device Risk, Safety, and Failures
He has experience in developing, writing, and submitting risk management related documentation to support Notified Body, 510k, PMA-S, and PMA submissions (Class I, II, and III). He has experience in the legal and safety requirements between 510k and PMA ... See full profile | | Minnesota (MN), USA | | | |  | | Expert in Medical Device Quick Prototyping/CAD Design/Concepting
Expert has designed and developed a cast base for biometric scanning. This base resulted in stable dimensions and functionality when subjected to change in temperature. Scans were used for both hand and finger ... See full profile | | Minnesota (MN), USA | | | |  | | Expert in Semiconductor Yield, Metal & Material Failure Analysis, Comprehensive Root Cause Analysis
Expert has performed over 200 failure analysis reports on semiconductor integrated circuit failures, metal component failures and machinery failures. Expert has the abilities to go deep in engineering and science and obtain the most likely root ... See full profile | | Minnesota (MN), 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 Medical Device Technology Coverage and Reimbursement, Clinical Trial Design, Protocol Development
For thirteen years, Expert was National Medical Director of Coverage and Reimbursement for Aetna and Health Net. In those roles he was responsible for developing Medical Policies stating the coverage and reimbursement decisions of the company ... See full profile | | Connecticut (CT), USA | | | |  | | Expert in Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. See full profile | | Oklahoma (OK), USA | | | |  | | Expert in Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals
Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO. In addition to filing and prosecuting patents, he also ... See full profile | | California (CA), USA | | | |  | | Expert in Medical Device Design and Analysis
He was responsible for providing product data for 510(k) submittals. He was responsible for developing devices and technology for patient gas monitoring devices, cardiac monitoring devices etc. He was responsible for the development of several ... See full profile | | New Jersey (NJ), USA | | | |  | | Expert in Medical Device Research and Development
Expert has over 30 years experience in medical device design dealing with all phases of design -- brainstorming, concept design, proof of concept testing, prototyping, cost / task estimating, project planning, project management, detailed design, ... See full profile | | Minnesota (MN), USA | | | |  | | 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 Medical Products Packaging: FDA Package Validation, Development Standards, Test Methods, ISO 11607
Expert has expertise in the field of medical device packaging for both single use disposable devices and for long-term implantable medical devices. His primary involvement has been in the design, development, and qualification of device ... See full profile | | Minnesota (MN), 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 Electrical and Biomedical Engineering, Patent Analysis
Expert is an expert in medical implants, devices and instrumentation; electrical and biomedical engineering; hospital x-ray and power systems; electrical power systems; electrical fire investigation; product safety and design deficiencies; ... See full profile | | Illinois (IL), USA | | | |  | | Expert in Medical Device Product Development; Machine Design; Biomedical Engineering
He performed research on adding an antimicrobial agent to a silicone rubber part molded using LIM. Research included materials, methods of molding, color changes, and effect of additive to biocompatibility. His library contains many materials available ... See full profile | | New Hampshire (NH), USA | | | |  | | Expert in FDA Medical Device Quality Systems, Governmental Registration Process, International Business, GMP
As an ex-FDA official for over 21 years (not only as a experienced investigator/analyst, but also when he acted as field and HQ compliance officers during details to these offices), Expert is highly familiar with FDA compliance. He retains this knowledge ... See full profile | | Pennsylvania (PA), USA | | | |  | | Expert in Microelectronics, Nanotechnology, Semiconductors, Memory
Expert has nearly 10 years of experience in solid state device development in a wide range of material systems. As a senior process engineer at Global Communication Semiconductors, he has provided internal advice about epitaxial layer selection from ... See full profile | | California (CA), USA | | | |  | | Expert in Biomedical Device Engineering
Biomedical product development; medical device product development; new product development. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. See full profile | | South Africa | | |  | | >> Next 25 Experts
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