Book of Donmon Teith

This book details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then hav

How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and

Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Gu

Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more

HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers bet