000 01831cam a2200277zu 4500
001 88955425
003 FRCYB88955425
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006 m o d
007 cr un
008 250108s2019 fr | o|||||0|0|||eng d
020 _a9780128161630
035 _aFRCYB88955425
040 _aFR-PaCSA
_ben
_c
_erda
100 1 _aPrivitera, Mary Beth
245 0 1 _aApplied Human Factors in Medical Device Design
_c['Privitera, Mary Beth']
264 1 _bElsevier Science
_c2019
300 _a p.
336 _btxt
_2rdacontent
337 _bc
_2rdamdedia
338 _bc
_2rdacarrier
650 0 _a
700 0 _aPrivitera, Mary Beth
856 4 0 _2Cyberlibris
_uhttps://international.scholarvox.com/netsen/book/88955425
_qtext/html
_a
520 _aApplied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation. Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU) Explains technology development and the application of human factors throughout the development process Covers FDA and MHRA regulations Includes case examples with each method
999 _c79174
_d79174