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510(k) document

  

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Medical Device Reporting regulation

 

510(K) Document Experts

The following experts are available as 510(k) document consultants and 510(k) document expert witnesses.  Intota experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  510(K) Document - The official document that is submitted to the Food and Drug Administration when seeking premarket approval for a medical device that is not life-supporting, implanted, or otherwise considered critical in sustaining life, such as a syringe or cloth bandage.
(Synonyms: 510k, medical device premarket notification)

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Expert 723272

Expert in Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness

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Expert in Medical Device Design and Development

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Expert in FDA Regulations, Labeling and Compliance; Medical Devices, Medical Products Liability

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Expert in FDA Regulatory Consultation for Medical Devices, Cosmetics, and OTC Drugs

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Expert in Intellectual Property

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Expert in Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants

Expert 722432

Expert in Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.

Expert 722724

Expert in EMC/EMI, RF/Microwave, Hardware, Firmware, Product Development

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Expert in Sutures, Medical Devices, Moisture Degradation, Absorbable Polymers, Implant Devices

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Expert in FDA Medical Device Regulation, Expert Testimony

Expert 725158

Expert in Medical Devices, In Vitro Diagnostics Design, Quality Control, Trouble-Shooting, etc.

Expert 725302

Expert in Medical Device Sterilization - Operations and Research & Development

Expert 725331

Expert in Medical Device Regulatory Submissions

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Expert in Medical Device Design and Analysis

Expert 726245

Expert in Implantable and Non-Implantable Medical Device Risk, Safety, and Failures

Expert 726891

Expert in International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance

Expert 727750

Expert in Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices

Expert 728193

Expert in Medical Device Product Commercialization from R&D to Manufacturing, Regulatory and Clinical Trials

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Expert in Medical Devices and Diagnostics; Life Sciences Products Development, Manufacturing, Marketing

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Expert in Biomedical Engineering; Medical Devices

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Expert in Medical Device, Biotech, Pharma R&D, Tech Transfer, Mfg, Compliance, IP Valuation, Process Improvement

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Expert in Medical Technology

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Expert in Medical Devices, CV Stents, Animal Models, Preclinical Testing, GLPs, Protocols, Data Capture Forms

Expert 711960

Expert in Wound Care Technical Product Development and Commercialization

Expert 714180

Expert in Telemedicine Configuration Testing and PACS Devices, Software QA, FDA Warning Letters, etc.

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