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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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 | Experts 1 to 25 of 65 |  | 510(K) Document Experts |  | Request Free Expert Quote |  |  | Expert 723272 |  | Expert in Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness |  |  |  |  |  | Expert 725237 |  | Expert in Medical Device Design and Development |  |  |  |  |  | Expert 108246 |  | Expert in FDA Regulations, Labeling and Compliance; Medical Devices, Medical Products Liability |  |  |  |  |  | Expert 713595 |  | Expert in FDA Regulatory Consultation for Medical Devices, Cosmetics, and OTC Drugs |  |  |  |  |  | Expert 711196 |  | Expert in Intellectual Property |  |  |  |  |  | Expert 721781 |  | 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 |  |  |  |  |  | Expert 724385 |  | Expert in Sutures, Medical Devices, Moisture Degradation, Absorbable Polymers, Implant Devices |  |  |  |  |  | Expert 724571 |  | 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 |  |  |  |  |  | Expert 726193 |  | 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 |  |  |  |  |  | Expert 728303 |  | Expert in Medical Devices and Diagnostics; Life Sciences Products Development, Manufacturing, Marketing |  |  |  |  |  | Expert 723204 |  | Expert in Biomedical Engineering; Medical Devices |  |  |  |  |  | Expert 107726 |  | Expert in Medical Device, Biotech, Pharma R&D, Tech Transfer, Mfg, Compliance, IP Valuation, Process Improvement |  |  |  |  |  | Expert 713381 |  | Expert in Medical Technology |  |  |  |  |  | Expert 711642 |  | 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. |  |  |  |  |  |  | >> Next 25 Experts
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