MDD Compliance Using Quality Management Techniques [Hardcover]

Ray Tricker (MSc IEng FIET FCIM FIQA FIRSE) (Author)

Book Description

Publication Date: February 25, 2000 | ISBN-10: 0750644419 | ISBN-13: 978-0750644419

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

Easy to follow guide to MDD
Written in clear, no nonsense format
Quality manual will provide template for any product being produced under MDD

Editorial Reviews

Review

'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

From the Publisher

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

See all Editorial Reviews

Product Details

• Hardcover: 608 pages
• Publisher: Butterworth-Heinemann (February 25, 2000)
• Language: English
• ISBN-10: 0750644419
• ISBN-13: 978-0750644419
• Product Dimensions: 9.2 x 6.2 x 1.8 inches
• Shipping Weight: 2.3 pounds
• Average Customer Review: 3.0 out of 5 stars  See all reviews (1 customer review)
• Amazon Best Sellers Rank: #1,950,443 in Books (See Top 100 in Books)

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Customer Reviews

Most Helpful Customer Reviews

3.0 out of 5 stars Medical Device Designer, June 8, 2009

By 

Ken who reads "Dedalusian" (Santa Cruz, CA.) - See all my reviews

This review is from: MDD Compliance Using Quality Management Techniques (Hardcover)

This book will be helpful to those who are manufacturing oriented. Design/development people will still have questions regarding how to navigate the MDD for compliance.