Richard C. Fries

Handbook of Medical Device Design (eBook, PDF)

• Format: PDF

Produktbeschreibung

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."

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 794
• Erscheinungstermin: 14. September 2000
• Englisch
• ISBN-13: 9781482290028
• Artikelnr.: 57531171

Autorenporträt

Richard C. Fries

Inhaltsangabe

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.