The future of the new GHTF: growing pains ahead?
This article was originally published in SRA
Executive Summary
Regulators have called it a day for their collaboration with the industry in the Global Harmonization Task Force for medical devices and instead are seeking to develop "a regulator-led harmonisation and collaboration group"1,2. Is this development an acknowledgment of the growing importance of the work or of the growing criticism that regulators are too close to industry? Or is it both?