Compiling an abundant catalog of the essential criteria and methods
for the design of medical devices, this comprehensive reference
supplies insights into a rapidly evolving field-spanning practical
knowledge, field tracking, valuable timesaving techniques, and the
latest innovations. Reviews current regulatory and standards
issues, including FDA regulations, types of 510 (k), the ISO 9000
series, and medical device directives Foreseeing a variety of
concerns and obstacles, the Handbook of Medical Device Design
identifies how to determine and document customer needs and device
requirements establishes reliability and quality metrics for the
duration of the product development cycle compares international
regulations and standards, in Europe, Canada, Japan, and Australia
illustrates electrical, mechanical, hardware, software, and
industrial design considerations discusses biocompatibility,
safety/risk analysis, third-party certification, technical
documentation, translations, and life-cycle costs of implantable
equipment thoroughly examines manufacturing processes such as
quality system regulation and preparation for the quality system
audit and more Includes useful appendices of tables and a glossary
Written by experienced practitioners and authorities in the field,
the Handbook of Medical Device Design is a necessary and worthwhile
reference and guidebook for biomedical, quality assurance,
reliability, software, product design, manufacturing, research and
development, and industrial engineers; project managers; biomedical
technicians, medical device purchasing personnel; and upper-level
undergraduate and graduate students in these disciplines.
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