ISO 13485:2003 and Medical Devices Harmonize
The European Commission has recognized EN ISO 13485:2003 as a harmonized standard for medical device manufacturing quality management systems for regulatory purposes under the three medical device directives, the Medical Device Directive, Active Implantable Medical Device Directive and I
The following article, the first of a two-part series, outlines the growing need for Six Sigma initiatives in the outpatient health care market.
From its inception, Six Sigma was considered revolutionary.