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