As the World Health Organization prepares for its first global medical devices forum, Michael Cheng calls on the WHO to bridge the gap – the role of the user – between its own guiding principles and the Global Harmonization Task Force's regulatory model.
During the early development of a global approach to ensure the safety and performance of medical devices – including the formation of the Global Harmonization Task Force – the terms “shared responsibility” and “risk management” were frequently used...
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