000			01666cam a22003618i 4500
999			_c12333 _d12333
001			20947612
005			20201220140944.0
008			190425s2020 flu b 001 0 eng
010			_a 2019015738
020			_a9780815365525 (hardback : alk. paper)
040			_aDLC _beng _erda _cDLC _dDLC
042			_apcc
050	0	0	_aR856.A2 _bT45 2020
082	0	0	_a610.28 _223 _bT.M.D
100	1		_aB.Teixeira, Marie. _eauthor.
245	1	0	_aDesign controls for the medical device industry / _cMarie B.Teixeira.
250			_aThird edition.
263			_a2020
264		1	_aBoca Raton : _bTaylor & Francis, _c2020.
300			_a263 pages ; _c24 cm
336			_atext _btxt _2rdacontent
337			_aunmediated _bn _2rdamedia
338			_avolume _bnc _2rdacarrier
500			_a"A CRC title, part of the Taylor & Francis imprint, a member of the Taylor & Francis Group, the academic division of T&F Informa plc."
504			_aIncludes bibliographical references and index.
505	0	0	_a Introduction -- Device classification -- Overview of design controls -- Design and development planning -- Design inputs: part I -- Design inputs: part II -- Design outputs -- Design review -- Design verification -- Risk management -- Design validation -- Biocompatibility -- Design transfer -- Design change -- Design history file -- The FDA inspection technique
650		0	_aMedical instruments and apparatus _xDesign and construction.
650		0	_aMedical instruments and apparatus industry.
906			_a7 _brix _corignew _d1 _eecip _f20 _gy-gencatlg
942			_2ddc _cBK