MDCG Position Paper on Hybrid Audits

Implemented during the pandemic and helped by new technologies, hybrid audits have become more frequent. A hybrid audit is an audit conducted on site and remotely.
MDCG definition of Hybrid Audit
In December 2022, the Medical Device Coordination Group (MDCG) published a position paper on hybrid audits. Firstly, the Group provides a definition of "hybrid audit":

A ‘hybrid audit’ should be understood as an audit on the premises of the manufacturer or its supplier(s) and/or subcontractor(s) with at least one auditor present on the premises and other members of the audit team participating from elsewhere using . . .


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