German integrated device standards proposed
This article was originally published in Clinica
Executive Summary
The full requirements of the new international quality system standard, ISO 9001:2000, should be integrated into the international medical device quality system standard, ISO 13485:2002, which is currently being revised. This is the opinion of the German medical device industry association, BVMed. "This would equally fulfil patients' demands for high quality medical devices and the economic interests of the manufacturers," said BVMed director Joachim Schmitt.