The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
Guidelines for Regulatory Auditing of Quality Management Systems of Medical DeviceManufacturers
Part 3: Regulatory Audit Report
This document gives guidance to regulators, auditing organizations and auditors on the
content of audit reports. However, it may also help the auditee understand and respond to
the audit findings.