Summary As the ultimate users of reports and certifications, regulators require that reports contain sufficient information to identify the manufacturer,

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Presentation transcript:

Summary As the ultimate users of reports and certifications, regulators require that reports contain sufficient information to identify the manufacturer, describe the parameters of the audit, support findings, and to conclude on the overall conformity and compliance of the manufacturer. The application of this guidance will lead to reports that consistently address these needs.

Summary Every audit is different and no guidance document can address all possible situations. Therefore, report authors should be guided by the principles presented earlier when preparing reports: - fair presentation - evidence-based approach - responsibility - positive reporting

Contact Information Quality System Section Medical Devices Bureau Health Canada (613) 952-8250 ISO13485CMDCAS_SCECIM@hc-sc.gc.ca http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/index-eng.php

Contact Information United States Food and Drug Administration Center for Devices and Radiological Health Office of Compliance (301) 796-6556 Robert.Ruff@fda.hhs.gov