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15 November 2022 - 12:58
Medical device fda label expert witness cv
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Medical device fda label expert witness cv












  1. MEDICAL DEVICE FDA LABEL EXPERT WITNESS CV SOFTWARE
  2. MEDICAL DEVICE FDA LABEL EXPERT WITNESS CV ISO

Clients working with HIEs, hospitals, and the hospital vendor and services industry benefit from our HIE industry experience. Standardization, security and openness are the cornerstones of the HIE programs, and are accomplished through standardized medical/technical terminology, use of existing HL7 standards in HL7, Privacy and secure transport using secure email protocols, National Institute of Standards and Technology (NIST)-adopted encryption standards, and open and accessible application programming interfaces (APIs). Initiatives to reach these goals are being developed and rolled out by the Office of the National Coordinator for Health Information Technology’s (ONC) Office of Science & Technology (OST).

  • Health Information Exchanges: The Health Information Technology for Economic and Clinical Health (HITECH) Act establishes the general goal of building national standards for exchange of healthcare information.

    • MEDICAL DEVICE FDA LABEL EXPERT WITNESS CV SOFTWARE

    Our recent work for major EHR vendors, hospitals, the ONC and the Office of Inspector General (OIG) regarding patient safety have been at the forefront of this complex and important industry.Our understanding of Meaningful Use, the 21st Century Cares Act, HIPAA, medical software standards and groups (ISO, IEC, IEEE, ANSI, AAMI), IDC-9/10 codes, PCT Codes, HL-7, patient safety and risk management frameworks, SDLC and quality testing methodologies, the Affordable Care Act (ACA), Medicare, Medicaid and private insurance reimbursements, serving as independent consultative experts, CARF accreditation, and more brings value to our clients in the field of medical office software. We understand the software used in all aspects of the provider/patient/practice interaction, from front-office clerical and scheduling, to doctor-patient encounters, to billing and claims management. Electronic Medical Record (EMR) and Electronic Health Record (EHR) systems are seeing maximum adoption while also dealing with the changes brought about by the Afforable Care Act (ACA) and Meaningful Use. EMR and EHR Systems: Our experts know the medical office software industry, and the changing environment in which it operates.

    medical device fda label expert witness cv

    Our experience with the FDA 510(k) Pre-Market Application (PMA) process, Quality System Regulations (QSR), 21 CFR Part 820, and other regulatory requirements adds value to our clients in the medical device industry.

  • FDA-Regulated Medical Devices: We have managed and implemented the software development and compliance program for FDA-regulated medical devices.

    • medical device fda label expert witness cv

    We serve as independent auditors for government and non-government organizations in the EHR space and have represented hospitals and EHR vendors cases relating the EMR/EHR software, CARF-accredited software, blood donation management software, medical device failure analysis, and more. We offer trusted and independent analysis in the changing world of EHR software standards and regulations.

    MEDICAL DEVICE FDA LABEL EXPERT WITNESS CV ISO

    Risk Management Frameworks such as ISO 14971.

    medical device fda label expert witness cv

  • Electronic health records (EHR) and electronic medical records (EMR).
  • CFR Part 820 (Quality System Regulation), CFR Part 11, ISO 13485.

    • medical device fda label expert witness cv

  • FDA-regulated devices and 510k submissions.
  • EHR accreditation through certified testing bodies (ONC-ATCB’s).














    • Medical device fda label expert witness cv
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