Medical Device Premarket Approval Experts
The following experts are available as medical device premarket approval consultants and medical device premarket approval expert witnesses. ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
Definition: Medical Device Premarket Approval -
A premarket approval assessment which is designed to test the safety and effectiveness of a medical device. Synonyms: medical device PMA
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Medical Device Premarket Approval Experts State: All AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Request Free Expert Quote Expert in Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design ... See full profile New York (NY), 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 Medical Devices; Product Development, Manufacturing, Marketing, Business practices, IP, commercial contracts, finance, M&A Expert has been the CEO or chairman of 7 medical device companies in 4 countries - 4 public, 3 private, and has been a member of the Board of Directors of 8 companies. He is an expert in areas of general and specific management of a medical device or ... See full profile Minnesota (MN), 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 Latin America Marketing Sales & Distribution - Spanish & Portuguese Expert has decades of experience in the manufacture and distribution of mining equipment and other industrial products throughout all of North and South America; and he applies his fluency in English, Spanish and Brazilian Portuguese - and his in-country ... See full profile Minnesota (MN), USA Expert in Product Development, Product Safety, Regulatory Compliance, Claims Support, Litigation Support This expert has training and experience in the following areas: Safety of foods, cosmetics and their ingredients; and medical devices, pharmaceutical actives and excipients. Regulatory affairs related to foods, cosmetics, and medical devices. See full profile Arizona (AZ), 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 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 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 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 Home Health Care, Home Infusion Therapy, Hospice, Molecular Diagnostics, Personal Assistance Service Expert is a highly accomplished Healthcare Senior Sales Executive with thirty plus years of experience founding, funding, developing and helping others develop Emergent Health Care Companies, building territories and leading teams to achieve and ... See full profile Texas (TX), 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 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 Medical Device Technology, Design and Manufacturing Expert is a seasoned engineer with over 25 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 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 Biomedical Engineering, Patents, Medical Device Design, Product Development, Eye Activity Devices, He has served as a consultant as well as trained and led numbers of team consultants in application software development projects for over 20 years. Masters Degree specializes in optics and diagnostic/remediative processes and devices based on eye ... See full profile Tennessee (TN), USA Expert in Medical Device Software, Medical Device Software Engineering, FDA Compliance, FDA 501K and PMAs for Software Expert has wide range of extensive hands on experience developing and manufacturing medical devices. Over the last twenty plus years he has successfully deployed several medical devices in the cardiovascular, opthalmic, and diagnostic industries. See full profile California (CA), USA Expert in Clinical Trial, Biomarker, Clinical Development, Drug Safety, Medical Affairs, Commercialization As a prescribing physician and a physician in drug development for many years, Expert has expertise in drug mechanism of action and clinical data, and clinical use. Expert is an expert in drug clinical development from planning to protocol design, ... See full profile Massachusetts (MA), USA Expert in Expert Witness Services, Product Development, product Design, Project Management Expert has been directly involved in the development of medical devices and their manufacturing processes for nearly forty years. These included ten years of responsible positions in industry, as well 30 years as the president of ... See full profile Washington (WA), USA Expert in Healthcare Consulting: Strategic Planning, Product Development, and Product Launch Expert has been providing expert strategic and operational advisory services to healthcare investors and development stage healthcare companies for nearly 10 years. He has been involved in direct healthcare management for over 15 years, and has been ... See full profile Massachusetts (MA), 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 Marketing Marketing; health care marketing; consumer product marketing. Expert has over 20 years of experience as a consultant and professor in the field of marketing. He has conducted market studies to develop and market health care systems, products, ... See full profile Florida (FL), USA Expert in Food Labeling; Food, Spring/Bottled Water, Drug and Medical Device Good Manufacturing Practices Expert was a California Food & Drug Investigator for 26 years enforcing federal GMPs and California health & safety codes. She has traveled throughout California inspecting a wide range of wholesale food, drug, and medical device manufacturers. See full profile California (CA), 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 >> Next 25 Experts