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

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

Leitlinie

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.