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    Study Group 1 - Study Group 1 Is Concerned With The Current Medical Device Regulatory

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    Sandeep kulkarni
    There are five study groups in the GHTF, each with different objectives related to medical device regulation, vigilance, quality systems, auditing practices, and clinical practices. Study Group 1 deals with current regulatory systems. Study Group 2 deals with medical device reporting and post-market surveillance. Study Group 3 deals with quality systems requirements and documents. Study Group 4 deals with auditing processes and guidelines. Study Group 5 deals with clinical practices convergence.

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    Study Group 1 - Study Group 1 Is Concerned With The Current Medical Device Regulatory

    Uploaded by

    Sandeep kulkarni
    13 views1 page
    There are five study groups in the GHTF, each with different objectives related to medical device regulation, vigilance, quality systems, auditing practices, and clinical practices. Study Group 1 deals with current regulatory systems. Study Group 2 deals with medical device reporting and post-market surveillance. Study Group 3 deals with quality systems requirements and documents. Study Group 4 deals with auditing processes and guidelines. Study Group 5 deals with clinical practices convergence.

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    There are five study groups in the GHTF, each with different objectives related to medical device regulation, vigilance, quality systems, auditing practices, and clinical practices. Study Group 1 deals with current regulatory systems. Study Group 2 deals with medical device reporting and post-market surveillance. Study Group 3 deals with quality systems requirements and documents. Study Group 4 deals with auditing processes and guidelines. Study Group 5 deals with clinical practices convergence.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    13 views1 page

    Study Group 1 - Study Group 1 Is Concerned With The Current Medical Device Regulatory

    Uploaded by

    Sandeep kulkarni
    There are five study groups in the GHTF, each with different objectives related to medical device regulation, vigilance, quality systems, auditing practices, and clinical practices. Study Group 1 deals with current regulatory systems. Study Group 2 deals with medical device reporting and post-market surveillance. Study Group 3 deals with quality systems requirements and documents. Study Group 4 deals with auditing processes and guidelines. Study Group 5 deals with clinical practices convergence.

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    of 1

     There are five study groups in the GHTF, each of with different objective

     Study Group 1 - Study Group 1 is concerned with the current medical device regulatory
    systems
     This group separates the principles suitable for harmonization as well as those that
    carriage a threat to harmonization. The Group also deals with the standardization of pre-
    market submissions and product labeling
     Study Group 2 - This Group is concerned with medical device vigilance such as medical
    device reporting and post market surveillance. The Group is designed to harmonize the
    data collection and reporting systems of the industry
     Study Group 3 - Study Group 3 is concerned with examining and harmonizing current
    quality systems requirements. Examples of documents put out by Study Group 3
    include Implementation of Risk Management Principles and Activities Within a Quality
    Management System and Quality Management Systems - Process Validation Guidance.
     Study Group 4 - Study Group 4 is concerned with examining current quality systems
    auditing practices and the harmonization of the auditing process. Examples of documents put out
    by Study Group 4 include Training Requirements for Auditors and Guidelines for Regulatory
    Auditing of Quality Management.
    Study Group 5 - Study Group 5 is concerned with the convergence of clinical practices. This
    includes the harmonization of clinical terms, reports and evaluations. Study Group 5 has yet to
    produce any final documents, but areas of proposed topics include Clinical Evaluation and
    Clinical Evidenc

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