This course is designed to familiarize quality and regulatory professionals, medical device designers and management with the additional requirements of ISO 13485:2003 and their interpretation. The quality system of requirements of EC directives 93/42/EEC (medical devices) and 98/79/EC (in vitro diagnostic medical devices) are also included to allow full understanding of quality systems required to achieve CE marking. The training has been designed to give you the necessary skills to perform internal audits on an organization’s Quality Management Systems (QMS) for Medical Devices to the requirements of ISO 13485:2003 and to contribute to their continual improvement.
