Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers –Part 1: General Requirements
Title:
Guidelines for Regulatory Auditing of Quality Systems
of Medical Device Manufacturers –Part 1: General Requirements
Origin/Publisher:
GHTF
Document Type:
Guidelines
Content:
This document provides guidelines for auditing organisations responsible for establishing, planning, carrying out and documenting audits of quality systems to address regulatory
requirements for manufacturers of medical devices.