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FDAnews Device Daily Bulletin
Nov. 9, 2012 | Vol. 9 No. 221
IMDRF Draft Attempts to Set Global Standards for Auditors
Organizations that audit device establishments must ensure their findings document conformity, nonconformity or potential nonconformity with established best practices based on objective evidence, according to a draft standard released by the International Medical Device Regulators Forum (IMDRF). Audit results, as well as manufacturer compliance with quality system management requirements and any certifications granted, must be provided to the relevant regulatory agency, the draft states.
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