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
"Management Guidance, Implementation Support, Documentation Assistance, Auditing Technique."
How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and
Prevention is the first line of defence in the fight against infection. As antibiotics and other antimicrobials encounter increasing reports of microbial resist
