EN 14971:2012 Content Deviation #6 and #7

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EN 14971:2012 Content Deviation #6 and #7

During the process of harmonisation of ISO 14971: 2007 as an EN standard, it became apparent that the standard did not comply with all the requirements of the Medical Devices Directives (MDDs), namely 90/385/EEC, 93/42/EEC and 98/79/EC. Seven discrepancies were identified; these ...

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