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Home » EU Device Group Defines Hybrid Audits, Loosens Auditor Presence Requirements
EU Device Group Defines Hybrid Audits, Loosens Auditor Presence Requirements
The EU Medical Device Coordination Group (MDCG) has proposed a new definition of hybrid audits, suggesting that there should be at least one auditor in a facility premises — at some point — during an audit by a notified body, with off-site team members participating using information and communication technologies.