000 02925cam a2200397Ka 4500
001 u380472
003 SIRSI
005 20160812084650.0
006 m o d
007 cr cnu---unuuu
008 121128s2012 xx a o 000 0 eng d
040 _aOPELS
_cOPELS
_dOCLCF
020 _a9780123919427 (electronic bk.)
020 _a0123919428 (electronic bk.)
029 1 _aAU@
_b000050608318
029 1 _aNZ1
_b15190907
029 1 _aDEBSZ
_b405345941
050 4 _aR856
_b.O37 2012
082 0 4 _a610.28
_223
049 _aTEFA
100 1 _aOgrodnik, Peter J.
245 1 0 _aMedical device design
_h[recurso electrónico] :
_binnovation from concept to market /
_cPeter J. Ogrodnik.
260 _a[S.l.] :
_bAcademic Press,
_c2012.
300 _a1 online resource :
_bill.
520 _aThis book provides the bridge between engineering design and medical devices development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices regulatory (FDA and EU) requirements: some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products' commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context, based on the authors' years of experience in academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the market place rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpels, stents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how. Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand. Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products.
588 _aDescription based on publisher supplied information; title not viewed.
650 0 _aBiomedical engineering.
650 0 _aEngineering design.
650 7 _aBiomedical engineering.
_2fast
_0(OCoLC)fst00832568
650 7 _aEngineering design.
_2fast
_0(OCoLC)fst00910453
655 4 _aElectronic books.
856 4 0 _zLibro electrónico
_3ScienceDirect
_uhttp://148.231.10.114:2048/login?url=http://www.sciencedirect.com/science/book/9780123919427
596 _a19
942 _cLIBRO_ELEC
999 _c207393
_d207393