The Quality System Compendium, 4th edition

CGMP Requirements and Industry Practice The fourth edition, provides a timely and comprehensive view of the rapidly evolving world of international medical device regulations. Since the 2015 publication of the third edition of this Compendium, the medical device regulatory landscape has undergone fundamental changes that impact many aspects of the global medical device community. This updated Compendium builds on the success of the third edition with new and expanded information directly relevant to today’s international medical device environment, including very readable and directly applicable material on such important topics as the Food and Drug Administration (FDA) 21 CFR Part 820 and ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), the EU Medical Device Regulation, the EU In Vitro Diagnostic Regulation, and evolving standards for software validation and risk management.