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

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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Sandeep kulkarni
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19 views1 page

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

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.

Uploaded by

Sandeep kulkarni
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© © All Rights Reserved
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 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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