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investigational medical device exemption regulation


medical regulation


medical device testing


medical device premarket approval


510(k) document


medical device product improvement


medical device manufacturing


new drug application


medical device


clinical trial


Experts in Investigational Medical Device Exemption Regulation

The following experts are available as investigational medical device exemption regulation consultants and investigational medical device exemption regulation expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Investigational Medical Device Exemption Regulation - A medical regulation pertaining to the testing of new medical devices prior to approval.

Synonyms:  IDE

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Experts in Investigational Medical Device Exemption Regulation
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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 Devices; Product Development, Manufacturing, Marketing, Business practices, IP
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 all areas of general and specific management of a medical device ... 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 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 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 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

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 International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance
Expert thrives on overcoming the quality and regulatory hurdles in the most time-efficient and cost-effective manner possible. He speaks fluent FDA, MDD and ISO 13485 and can converse successfully in CMDCAS, PAL, TGA, SFDA and KFDA as well. See full profile

Wisconsin (WI), 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 Medical Device Design and Manufacture
Expert has over 25 years experience in the conception, design, and manufacture of medical devices. Experience ranges from high volume disposables to low volume implantables. Beginning as a manufacturing engineer responsible for all facets of device ... See full profile

Minnesota (MN), 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 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 Oxygen Therapy & Conservation, Biofeedback, Clinical Management Design, Electronics, & Prototyping
Expert has extensive clinical experience in asthma management and served on the ATS Standards Committee for COPD (Chronic Obstructive Pulmonary Disease) published in 1995. He developed an asthma clinical guidance system, developed three ... See full profile

California (CA), USA

Expert in Medical Device Design and Manufacturing: Laboratory Devices, Surgical Instruments, and Disposables
Expert has expertise in the design and development of laboratory devices, surgical instruments, and disposables for the biotechnology, pharmaceutical, medical device, electronic, cosmetic, and consumer product industries. See full profile

California (CA), 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 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 Medical Device Marketing, Market Research, Competitive Analysis, Business Analytics, Medical Writing
Expert has over 12 years of marketing experience in the Class III and Class II medical device industry, specializing in new product launches, new product development, market research and marketing communications. She is highly skilled in analytics, ... 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 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 Skin Care, Dermatologic Products and Cosmetics, Cosmetic Skin Surgery
As a board certified dermatologist involved in clinical care for the past 25 years, and an Associate Clinical Professor of Dermatology at Mount Sinai School of Medicine, and an author of numerous books, by-line articles, and audiotapes on skin care and ... See full profile

New York (NY), USA

Expert in Virology, Drug Discovery, Diagnostics, Bioterrorism, and Vaccines
Expert has spent over 20 years in the pharmaceutical and diagnostics industries. During that time he has been involved primarily in viral vaccine and antiviral drug discovery, although he has also run ... See full profile

Suffolk, 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


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