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Will the US be alone in sticking to own quality system regulations

This article was originally published in Clinica

Executive Summary

The US FDA has made it clear that it is not going to be sidetracked from its quality system regulation (QSR) despite the recent revision of the global quality management system standard for medical devices, ISO 13485:2003. But does this mean that the US authorities are stubbornly holding onto an outdated system, or are matters better than they seem?

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