GHTF Guidance Ignites Labeling Concerns for Orthopedic Manufacturers


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GHTF Guidance Ignites Labeling Concerns for Orthopedic Manufacturers

Translation of labeling is now under more
intense scrutiny.

Orthopedic Design & Technology - March/April 2006

The Global Harmonization Task Force (GHTF) was founded in 1992 in response to the growing need for international harmonization in the regulation of orthopedic and
other medical devices. Chairmanship of the GHTF is rotated among the five Founding Members: the European Union, the United States, Canada, Australia and Japan.

The purpose of the GHTF is to encourage convergence in regulatory practices related to safety, effectiveness, performance and quality—promoting technological innovation and facilitating international trade. The primary means by which these goals are accomplished is via the development and publication of harmonized guidance documents on basic regulatory practices. Recently, the GHTF issued an important guidance (SG3/N15R8), based on ISO 13485:2003 and ISO 14971:2000, that has crucial implications for translation vendors serving orthopedic and other medical device manufacturers. Read More

—Marc Miller, Crimson Life Sciences

 
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