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Handbook of Medical Device Design
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| List Price: | £178.00 |
| Price: | £169.10 & eligible for FREE Super Saver Delivery on orders over £5. Details |
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Product Description
A review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives, this handbook identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include software standards and design, product requirements, hazard and risk analysis, biocompatibility, verification and validation, intellectual property, and analysis of test results and field data. According to E-Streams, "…Biomedical and engineering libraries would benefit from this addition to their reference collections."
Product Details
- Amazon Sales Rank: #805126 in Books
- Published on: 2000-09-14
- Original language: English
- Number of items: 1
- Binding: Hardcover
- 774 pages
Editorial Reviews
Review
"a worthwhile reference and source. . ..Biomedical and engineering libraries would benefit from this addition to their reference collections." ---E-Streams
From the Back Cover
The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include
