Overview

The Medical Devices Directive (MDD) is an all-encompassing document legislating for the manufacture of any medical device or material used either temporarily or permanently on or in the human body. To achieve its main objectives the MDD requires the manufacturer of all products covered by the Directive to possess a fully auditable Quality Management System consisting of Quality Policies, Quality Procedures and Work Instructions, based on the ISO 9000 standard. The book is based on the sound principles of ISO 9000 and will guide to the reader, if required, to eventually set up an ISO 9000 fully compliant system. MDD-Compliance using Quality Management Techniques consists of the following: * A brief guide to the Medical Devices Directive - explaining the main requirements of the directive, translating legal Eurospeak into everyday language * An overview of ISO 9000 and how the MDD links in with these international requirements. * A Quality Manual - will provide a template for a complete Quality Management System that can be used by any product being produced under the requirements of the MDD * CD ROM containing a software copy of the Quality Manual * A User manual consisting of clear instructions and flow charts on how to set up and use the Quality Management System described in the Quality Manual

Full Product Details

9780750644419

Table of Contents

Reviews

'The medical device directive (MDD) is difficult to understand and interpret, but this book covers the subject well...In summary, the book is a good reference for understanding the medical device directive's requirements and would aid companies of all sizes in adding these requirements to an existing QMS.' Quality World, August 2001 An easy to follow guide to the Medical Devices Directive. Written in a clear, no nonsense format the manual will provide a template for any product being produced under MDD. Hospital Equipment and Supplies

Author Information

Ray Tricker served with the Royal Corps of Signals (for a total of 37 years) during which time he held various managerial posts culminating in being appointed as the Chief Engineer of NATO ACE COMSEC. Most of Ray's work since joining Herne European Consultancy Ltd has centred on the European Railways. He has held a number of posts with the Union International des Chemins de fer (UIC) (e.g. Quality Manager of the European Train Control System (ETCS), European Union (EU) T500 Review Team Leader, European Rail Traffic Management System (ERTMS) Users Group Project Co-ordinator, HEROE Project Co-ordinator) and currently (as well as writing books!) he is busy preparing a complete Quality Management System for the European Rail Research Institute (ERRI) in Holland, aimed at gaining them ISO 9000 accreditation in the near future. He is also consultant to the Association of American Railroads (AAR) advising them on ISO 9001:2000 compliance, and has recently been appointed Fellow of the Institution of Railway Signal Engineers (FIRSE).

Tab Content 6

Customer Reviews

Recent Reviews

Countries Available