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medical device registration


Medical Device Registration Experts

The following experts are available as medical device registration consultants and medical device registration expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Medical Device Registration - Obtaining clearance, authorization and approval from regulatory agencies prior to the sales and marketing of any instrument, apparatus, appliance, material, or other article, intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment, or alleviation of disease, injury, disorder or condition.

Synonyms:  medical device premarket notifications 510k

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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 Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). See full profile

Minnesota (MN), USA

Expert in Product Approval and GMP Compliance to Medical Device Regulations
As compliance officer with the CDRH's Office of Compliance, expert was responsible for evaluating results of foreign and domestic inspections conducted by the agency based on current Good Manufacturing Practice Regulations. His experience with the FDA has ... See full profile

Virginia (VA), USA

Expert in Medical Product Design and Development
I have nearly 20 years professional experience with product development and manufacturing. This is ignoring the extensive experience I gained in my own time beginning at a very young age. For example, by age 10 I was experimenting with lasers and ... See full profile

California (CA), USA

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 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 Healthcare Information Technology, Biomedical Device Integration, Clinical Informatics
Expert has more than 28 years experience in mathematical analysis, mathematical analysis techniques and in the use of mathematical analysis for signal processing, simulation techniques and has experience over that time span in developing both simulations ... See full profile

Maryland (MD), USA

Expert in Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. See full profile

Oklahoma (OK), USA


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