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Medical Regulation Experts

The following experts are available as medical regulation consultants and medical regulation expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Medical Regulation - A regulation pertaining in some way to the medical field, such as a medical device regulation, or a medical waste management regulation.

Synonyms:  medical code, medical law, medical ordinance, medical rule, medical statute

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Medical Regulation Experts
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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 Software, Medical Device Software Engineering, FDA Compliance, FDA 501K and PMAs
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 Professional QA & Regulatory Compliance for Medical Devices, Plastics Process Qualification
Expert has over 30 years of experience as a quality improvement professional, providing technical and managerial quality systems management. His base is a select group of processes within which we maintain current knowledge and process engineering skills. See full profile

North Carolina (NC), USA

Expert in Animal Models, Preclinical Testing, GLPs, Protocols, Data Capture Forms, Veterinary Medicine
Expert has a significant amount of experience with developing animal models through discussions with cross-functional groups and considerable expertise in veterinary surgery and biomechanics. He has experience with animal models for the cardiovascular, ... See full profile

Michigan (MI), 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 FDA Regulatory Consultant for Medical Devices, Cosmetics, and OTC Drugs
Expert is a renowned authority in the cosmetic, OTC drug and medical device industries. He has had over 40 years of experience dealing with regulatory, scientific, and technical issues for FDA regulated industries. He served as Senior Vice ... See full profile

Maryland (MD), 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 Commercialization of Scientific Devices, Inventions, Scientific Management Consulting, etc.
Expert has used his experience and knowledge of biochemistry and biophysical measurement to create tools for measurement of clinically significant targets for the biomedical industry. He has developed Drugs of Abuse and many other assays, supported the ... See full profile

Illinois (IL), 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 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 Bioethics, Medical Ethics, Ethnography Research, Qualitative Research, Good Clinical Practice, Medic
Expert is a professional bioethicist and works seamlessly among clinicians, entrepreneurs, venders, and business owners addressing critical healthcare issues such as ethics, risk, policy, content, technology, and quality care. She provides leadership to ... See full profile

Pennsylvania (PA), USA

Expert in Medical Statistics, with a special interest in Evidence Synthesis and Meta-Analysis
Expert (R) Expert has 30+ years experience as an academic medical statistician. His areas of interest and expertise include clinical trial methodology; he was a member of the UK medicines regulatory body, The Committee on Safety of Medicines. See full profile

United Kingdom

Expert in Medical Waste Management
Expert holds a Master's degree in Public Health from University of Connecticut and has been involved in the healthcare waste industry for over 21 years. His experiences cover all facets of the healthcare waste management arena from assessment of ... See full profile

Connecticut (CT), USA

Expert in Healthcare, Medical Device, Diagnostics, Pharmaceuticals coding, reimbursement
Expert, MD FACP AGAF FASGE FACG is a physician whose focus is strategy for coverage, reimbursement, quality improvement, bundled payments and accountable care. He is Board Certified in Internal Medicine and Gastroenterology. He has run risk-bearing ... See full profile

Arizona (AZ), USA

Expert in Obstetrics and Gynecology
After becoming and ordained minister and conducting a 9 year extensive medical education at institutions on each coast (including California and Washington D.C.) expert served in a vast range of medical duties. He holds licenses to practice in Maryland, ... See full profile

Virginia (VA), 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 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 EMC/EMI, RF/Microwave, Hardware, Firmware, Product Development
Expert has expertise in the design of biomedical imaging products, providing patient safety and comfort regarding ISO and FDA requirements. He is an Adjunct Professor teaching on biomedical instrumentation including cardiac, ultrasonic equipment, pressure ... See full profile

Arizona (AZ), USA

Expert in Electrical and Biomedical Engineering, Patent Analysis, Medical Devices, Electrical Trauma
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 Midwifery, Law and Ethics
Expert has been a practicising midwife, both in consultant and midwifery led care for the past 12 years. She holds current registered midwife status with the UK nursing and midwifery council. Has completed an LLM (masters degree) in medical law and ... See full profile

United Kingdom

Expert in Medical Negligence, Disability, Accident Investigation, Occupational and Aviation Medicine
Expert has applied his wide experience in Medicine, Occupational and Aviation Medicine into his practice as an Expert Witness. He spent 5 years as a Home Office Refereee and susequently when the system was changed as a Selected Medical Practitioner. See full profile

Hampshire, United Kingdom

Expert in Biomedical Engineering; Medical Devices
Ip Projects Catheter stabilizing device Dental Instrument Implant Seeds Intrauterine pressure catheter Vascular Catheters (3) Over 30 years experience in medical product design and development experiences in Anesthesiology, Assistive Technology, ... See full profile

Illinois (IL), 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 Orthopaedic Biomaterials
Biocompatible metals, polymers, and materials. Most of Expert's professional experience is in both synthetic and natural materials. For the last 20 years he has worked with absorbable and non-absorbable polymers and ... See full profile

Louisiana (LA), USA

Expert in Health & Human Services, Expert Witness
Expert provides Standard of Care opinions related to quality of care and treatment provided by health, education and human service agencies. He has extensive training and experience in health and human service management, special education, quality ... See full profile

Kansas (KS), USA

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