is being presented by Theo Nusselder, Founder & Director, of cePartner4u and airs on Tuesday, March 30, 2010. For more details or to register, please visit our site at www.fxconferences.com
Are you ready for a Notified Body audit? The European Medical Devices Directive requires that manufacturers of medium- and high-risk devices apply for an assessment of the manufacturing process and the technical documentation. The manufacturer is responsible for the design, manufacture, packaging and labeling of a device before it is placed on the market, regardless of whether these operations are carried out by the manufacturer or outsourced to a third party. The quality system must ensure that the products conform to the requirements of the Directive at every stage, from design to final inspection.
The Notified Body must audit the quality system to determine whether it meets the requirements, and the auditors have thorough knowledge of the rules on the inspections. Such rules are given in ISO requirements for audit and certification of management systems (ISO 19011:2002) and GHTF guidelines for Regulatory Auditing of Medical Device Manufacturers (GHTF/SG4/N28R4:2008). In this audio conference presentation attendees learn how to use these rules as a guide to Good Auditing Practice for the Notified Body assessment and CE-certification procedures.
