Module 19 2021

24/05/2021

STED = Summary Technical Documentation What is STED?

The Organisation for Professionals in Regulatory Affairs

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STED: Summary Technical Documentation

‘It is advantageous to both RAs/CABs … if a subset of this technical documentation is used for … conformity assessment activities. This technical documentation subset is intended to be in a consistent, summarised or abridged form, with sufficient detail to allow the RA/CAB to fulfil its obligations.’

http://www.imdrf.org/documents/doc-ghtf-sg1.asp

The Organisation for Professionals in Regulatory Affairs

38

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