Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy
Title:
Guidelines for Regulatory Auditing of Quality Management
Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy
Origin/Publisher:
GHTF
Content:
This document gives guidance to regulators and auditing organizations conducting audits
of quality management systems of medical device manufacturers based on the process
approach to quality management system requirements (e.g., ISO 13485:2003 and 21 CFR
Part 820).