The Global Harmonization Task Force (GHTF) issued a new guidance document on a regulatory model. The guidance diagrams a model, from a few different views, and shows how the guidance documents from the GHTF’s Study Groups fits into the model. While starting with a simple life-cycle model for devices, the guidance refines it into a more comprehensive approach, showing how each GHTF Study Group’s documents fit into the refined model.
The document includes tables that delineate the role and responsibility of some stakeholders in the regulatory system, i.e., manufacturers, regulators, and conformity assessment bodies. The guidance also includes a bibliography of GHTF and ISO documents that factor into the regulatory scheme.
Readers may obtain the document from the GHTF website (www.ghtf.org) or from the Ombu Library.