Quality Management System - Medical Devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange
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Quality Management System - Medical Devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange
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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.