Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-wor

Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-wor

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

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

This book provides a clear, easy to digest overview of Quality Management Systems (QMS). Critically, it offers the reader an explanation of the International St