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Search results with tag "Technical documentation and medical device regulation"
Technical Documentation and Medical Device Regulation
www.medical-device-regulation.euthe device to the NB for pre-market or post-market conformity assessment activities. With the aim of globally standardizing medical device regulatory submissions, the Global Harmonization Task Force (GHTF) has created the ‘Summary Technical Documentation (STED)’, intended to be a consistent, summarized or abridged form of the
Technical Documentation and Medical Device Regulation
www.bsigroup.comA subset of the information contained in the technical documentation is used by the manufacturer, when submitting the device to the NB for pre-market or post-market conformity assessment activities. With the aim of globally standardizing medical device regulatory submissions, the Global Harmonization Task Force (GHTF) has created