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Expert Quote | | |  | | Expert in Manufacturing Automation, Statistical Process Control
Expert has more than thirty years of experience in the analysis of process and manufacturing data aimed at improving product quality and manufacturing process yield. While at DuPont he developed a technology to uncover latent ... See full profile | | Delaware (DE), USA  | | | |  | | Expert in Biomedical Engineering, Manufacturing Engineering, R&D
Expert has over 20 years of experience in the research and development of medical devices for: electrodes for transcutaneous sensing and stimulation (EKG, EEG, EMG, TENS, defibrillation, pacing); respiratory therapy, specifically ... See full profile | | California (CA), 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 Medical Device Product Commercialization from R&D to Manufacturing, Regulatory and Clinical Trials
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 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 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 PRODUCT DESIGN AND MANUFACTURING (MEDICAL DEVICES, ELECTRONICS, OPTO-MECHANICAL)
For the last 20 years I was designing product and piecing up various parts using different material and process. My expertise in designing Plastics parts sheet metal and metal casting and working with supplier to deliver on time the parts and sustaining ... See full profile | | British Columbia, Canada | | | |  | | Expert in Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant ... See full profile | | Illinois (IL), USA | | | |  | | Expert in Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles to the ... See full profile | | Germany | | | |  | | 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 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 Disposable Medical Device Manufacturing
Expert has extensive experience in the areas of disposable medical devices. Utilizing his B.S. in Plastics Engineering and 20+ years experience in medical device manufacturing, Expert assists start-ups and Fortune 500 Medical Device OEM's with their medical ... See full profile | | Massachusetts (MA), 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 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 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 Devices, In Vitro Diagnostics Design, Quality Control, Trouble-Shooting, etc.
Expert has authored and submitted 510(k)s for more than 25 IVD (In Vitro Diagnostics) products. These 510(k)s encompass a variety of IVD products from manual, semi-automated to fully automated non-isotopic diagnostic tests including point-of-care devices. See full profile | | California (CA), USA | | | |  | | Expert in Medical Device Total Quality
Fda regulation. a significant portion of Expert's career has been devoted to FDA approval and regulation of medical devices, particularily those with significant risk. He is the President of Expert Consulting Inc. See full profile | | Washington (WA), USA | | | |  | | Expert in 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 ... See full profile | | New Jersey (NJ), USA | | | | | | Expert in Quality Assurance Engineering
Expert has over 15 years of experience with quality assurance. He provided Quality Assurance support to insure timely and cost effective: systemic, design, component and product compliance. His activities included supporting: New Product Development, ... See full profile | | Nevada (NV), 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 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 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 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 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 Sterilization, Medical Device QA, GMP Audit, Supplier Audit, SOP's
Expert, Expert's Firm Principal, is highly regarded in the medical device and sterilization industries. Areas of expertise include: medical device sterilization (Radiation and EO), quality systems development and assessment, sterilization ... See full profile | | California (CA), USA | | |  | | >> Next 25 Experts
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