Faithin Omaha eBook Collection

The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 134

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

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

The field guide depicts step by step what must occur for organizations to create an effective environmental management system (EMS) in conformance with ISO 1400