GHTF spells out conformity assessment criteria for IVDs
This article was originally published in Clinica
The latest final document posted by Study Group 1 of the Global Harmonisation Task Force (GHTF), which focuses on premarket evaluation, concerns the principles of conformity assessment for IVDs. This is the second final document to be posted this year on IVDs; the first, posted in June, concerned the principles of IVD classification.
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