Handbook of Medical Device Design

Handbook of Medical Device Design

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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 includeThe goal was to make computer system procurement activities more uniform. a€c 1974 - The US Navy began development of Mil-Std 1679, Weapons System Software Development. ... program specifications, database specifications, user manual, operations manual, program maintenance manuals, test plan, and test analysis report. ... Assurance Plan was approved for trial use a€c 1979 - FDA issued first notice of its intent to use consensus standards as part of the regulatory process.

Title:Handbook of Medical Device Design
Author:Richard C. Fries
Publisher:CRC Press - 2000-09-14


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