Handbook of Medical Device Design

en Limba Engleză Hardback – 14 sep 2000

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

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Specificații

ISBN-13: 9780824703998
ISBN-10: 0824703995
Pagini: 794
Ilustrații: illustrations, glossary
Dimensiuni: 152 x 229 x 41 mm
Greutate: 1.63 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press

Public țintă

Professional

Cuprins

Standards and regulations: FDA regulations; preparing an FDA submission; European standards and regulations; the medical device directives; the basics of ISO 9001; design of medical devices for the Canadian market; Pacific Rim standards and regulations; overview of software standards. Determining and documenting requirements: defining the device; documenting the product requirements; medical device records. The design phase: hazard and risk analysis; hardware design; software design; human factors engineering; biocompatibility; reliability assurance; product user guides; translation - it's a small world after all; liability; intellectual property. Verification and validation: testing; overview of verification and validation for embedded software in medical devices; software verification and validation; reliability evaluation; analysis of test results. The manufacturing/field phase: quality system regulations and manufacturing; configuration management; the quality system audit; analysis of field data. Appendices: Chi Square table; percent rank tables.

Recenzii

"a worthwhile reference and source. . ..Biomedical and engineering libraries would benefit from this addition to their reference collections."
---E-Streams

Descriere

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. Italso 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.”

Notă biografică

Richard C. Fries is Manager of Reliability Engineering, Datex-Ohmeda, Inc., Madison, Wisconsin.

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