Reliable Design of Medical Devices [Hardcover]

Richard C. Fries (Author)

Book Description

Publication Date: January 30, 1997 | ISBN-10: 0824798430 | ISBN-13: 978-0824798437

Presenting the basic concepts and major issues associated with medical device design, this text describes current development processes as well as standards and regulatory information, providing a basis for assessing new technologies. It aims to help manufacturers establish and operate a viable reliability assurance programme, and purchasers to formulate effective methods of vendor evaluation.

Editorial Reviews

About the Author

Fries; Richard Baxter Healthcare, Round Lake, Illinois, USA,

Product Details

• Hardcover: 728 pages
• Publisher: CRC Press (January 30, 1997)
• Language: English
• ISBN-10: 0824798430
• ISBN-13: 978-0824798437
• Product Dimensions: 9.2 x 6.2 x 1.5 inches
• Shipping Weight: 2.2 pounds
• Average Customer Review: 5.0 out of 5 stars  See all reviews (1 customer review)
• Amazon Best Sellers Rank: #3,801,673 in Books (See Top 100 in Books)

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Customer Reviews

Most Helpful Customer Reviews

6 of 6 people found the following review helpful:

5.0 out of 5 stars Excellent reference, April 24, 2009

By 

Yuri Kuzyk (Toronto, Ontario Canada) - See all my reviews

This review is from: Reliable Design of Medical Devices, Second Edition (Hardcover)

This book provides a solid reference for the Systems Engineer who is working on a medical device, including for IVD devices. The book is specifically structured to cover the design process and important documentation requirements in order to meet FDA 510(k) submissions. It also introduces the more typical reliability design process approach used in other industries such as telecommunications, to the design of medical devices.

The chapters of the book develop many areas of the engineering design process specific to biotechnology. The book covers the important area of 14971 Risk Assessment requirements and how this standard impacts the engineering design process. The book provides good ideas for incorporating 14971 into the standard engineering design process.

The book is useful for both medical devices (60601 requirements) as well as providing guidance for IVD devices. It lists many references for the medical systems engineer. I highly recommend it as a reference book.