Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical industry

The guidelines contained in this European Standard are applicable to a quality system as specified by EN 29001 and EN 46001 or EN 29002 and EN 46002. This European Standard does not add to, or otherwise change the requirements of those standards, and is not intended to be used directly in the assessment of a supplier's quality system. The guidelines provide concepts and objectives which should be considered by a supplier of active medical devices while developing and maintaining his quality system. This European Standard: - provides examples of how to meet the requirements, while recognizing that other methods which achieve the same ends are equally acceptable; - gives general advice on how to meet the requirements; - draws attention to aspects of requirements that may not be readily apparent to those unfamiliair with quality systems used in the active medical device industry.