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Last Friday, after a three year gridlock, the Council of the European Union came to an agreement on the reworking of regulatory legislation on medical devices and in vitro diagnostics which will impact both...
by Priya Bhutani, CEO RegDesk – Summary Technical Document (STED) is the proposed harmonized format used for regulatory submissions by the Global Harmonization Task Force (GHTF). Albeit STED is in its pilot...