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.
Quality Management System - Medical Devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange
Internet:
Origin/Publisher:
Document Type:
Guideline
Content:
This document provides a method to present outcomes of regulatory audits that can be used by regulatory authorities for information exchange. It introduces a nonconformity grading system for regulatory purposes with a Regulatory Audit Information Exchange Form providing standardized results.
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