Closed working groups
Closed working groups
Registries of patients undergoing medical device procedures represent a growing potential electronic resource for local and global medical device evaluation and tracking.
Review and update the GHTF/SG1/N045:2008 Principles of In Vitro Diagnostic (IVD) Medical Devices Classification.
Improve the effectiveness and efficiency of the pre-market review process by promoting increased global harmonization.
Development of non-binding rules for creating, using, and maintaining unique device identifiers and related activities.
IMDRF recognized standards.
Leverage regulatory resources to manage an efficient, effective, and sustainable single audit program.
Review the GHTF NCAR Exchange Program and to advise on opportunities for improvement
Develop international definitions, risk category framework, and quality management system.
Development of non-binding rules for creating, using, and maintaining unique device identifiers and related activities.
Improve the process of developing international standards used for regulatory purpose in the medical technology domain.