• 

medical device clinical research

clinical research

medical device reliability testing

Good Clinical Practice

Safe Medical Devices Act of 1990

biocompatibility testing

medical device liability

Medical Device Reporting regulation

medical device reporting

medical device sterility

home health care

biomedical device design review

medical device manufacturing

medical device

FDA medical device regulation

biomedical device manufacturing

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 Cardiac Electrophysiology, Cardiology Drugs, Pacemakers, Defibrillators, Cardiac Medical Devices
Expert is a board certified cardiac electrophysiologist (cardiologist with expertise in the diagnosis and treatment of all cardiac rhythm disorders) with over 20 years experience as a clinical investigator, IRB Chair, and high volume implanter of ... See full profile

Pennsylvania (PA), 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 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 Plastic and Reconctructive Surgery, Lymphedema, Medical Device Design, some Stem Cells technology
Expert has been a practicing plastic and reconstructive surgeon for 15 years. He has been the Medical Director of a Division of Plastic Surgery as well as a current Medical Director of a state certified out patient surgery center. See full profile

Arizona (AZ), USA

Expert in Drug and Vaccine Adverse Effects, Standard of Care, Hepatitis
Expert is board certified in internal medicine with a focus on biomedical clinical research. He received his PhD in immunology and medical genetics from the Department of Microbiology at UCLA in 1977. He also received his MD from UCLA in 1980 and ... See full profile

Alabama (AL), USA

Expert in Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market
She has advised many International clients with regards to requirements for dossiers as well as routemap for ANDA Procedure in addition to the requirements for DMF dossier as well as routemap for EDQM Certificate of Suitability Procedure. See full profile

Netherlands

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 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 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 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 Pharmaceutical/Biotech Clinical Trials, Regulatory, R&D, Mergers & Acquisitions, Trends, Outsourcing
Expert is Director of Regulatory Affairs and Clinical Trials managing $3.6 billion at at a pharmaceutical company in New York, NY. His expertise is in managing and deploying outsource/insource teams worldwide for multiple clinical trials and ... See full profile

Michigan (MI), 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 Telecommunications
Provides strategic value to those involved with the Virtual Practice of medicine. Expert received his M.D from New York Medical College with Alpha Omega Alpha honors. He trained in obstetrics and gynecology. He is Clinical Professor at the UCLA School ... See full profile

California (CA), USA

Expert in Biomedical Engineering and Patents, Biomedical & Electrical Device Designing, 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. Completed coursework for Masters of Biomedical Engineering. Thesis being completed specializes in optics ... See full profile

Tennessee (TN), 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 Image Guided and Robotic Surgery Design, Neurosurgery, Stereotactic & Functional Neurosurgery, etc.
Expert has developed technology involving image guided neurosurgery, robotic surgery, and computerized stereotactic techniques, and has been awarded patents for (1) measurement of cerebral blood flow by computerized tomography, (2) method and ... See full profile

Texas (TX), 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 Clinical Trial and Drug Safety in New Drug Development and Marketing/Commercialization
Expert has a working knowledge of ICH guidance related to patient protection and relevant US laws. 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 ... See full profile

New Jersey (NJ), 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 Business Development, Strategic Planning, Due Diligence, and Product Development
Expert has a doctorate in Biomedical Engineering and remains current with many of the advances in this field. He currently sits on the grant selection committee for the National Research Council of Canada. He has performed numerous consulting ... See full profile

Ontario, Canada

Expert in Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for Lyme ... See full profile

New Jersey (NJ), 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 ... See full profile

Massachusetts (MA), USA

Expert in Hearing and Speech Science, and Audio Signal Processing
Expert offers comprehensive expertise in audio signal processing, including speech, audio, and music. His role can cover basic research, conceptual development, project management, feasibility studies, literature searches, experiment design, and product ... 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

New Jersey (NJ), USA