MDD Compliance Using Quality Management Techniques; Author: Tricker, Ray; Paperback; Floppy disk, diskette

Author: Tricker, Ray
Paperback; Floppy disk, diskette; Illustrations
256 pages
Published: December 1999
Butterworth-Heinemann
ISBN: 0750644419
This item non-returnable. Order may not be canceled.

The Medical Devices Directive (MDD) passed by the EEC in June 1998 requires manufacturers of medical devices and/or associative equipment to have in place a fully auditable quality management system. This guide assists small and medium sized in meeting this requirement, and also can be useful for ISO 9000 quality certification. It describes the 20 elements that make up ISO 9001:1994 andthe additional quality management requirements which are specifically required to comply with MDD.Based on the principles of ISO 9000, this pack guides the reader, if required, to eventually set up an ISO 9000 fully compliant system. It features a guide to the Medical Devices Directive, an overview of ISO 9000, a quality manual, a user manual, and a floppy disk.