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Critical EU standards issues still need to be ironed out before adoption of new Regulations

This article was originally published in Clinica

Executive Summary

The latest versions of some of the EU’s most critical medical device standards have yet to emerge from the wings, as have solutions to the persistent problem of linking standards to the medical device directives’ Essential Requirements. Amanda Maxwell met with Andy Vaughan*, vice-chair of the Advisory Board for Healthcare Standards (ABHS) within CEN-CENELEC, the European Standardization Organizations, to find out what progress is being made






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