000			01542cam a2200241 i 4500
008			130919s2014 flu b 001 0 eng
020			_a9781466503540 (hardcover : alk. paper)
041			_aeng
082	0	0	_a610.28 _223
100	1		_aTeixeira, Marie B., _d1965-
245	1	0	_aDesign controls for the medical device industry / _cMarie B. Teixeira.
246	3	0	_aMedical device industry
250			_a2nd ed.
260			_aBoca Raton : _bCRC Press, _cc2014
300			_axii, 193 p. ; _bill. ; _c25 cm.
504			_aIncludes bibliographical references (pages 181-182) and index.
520			_a"Design control is a key element of a company's quality management system and is mandated by the U.S. FDA's Quality System Regulation under article 820.30 for most medical devices. Medical device companies wishing to comply with ISO 13485 to meet international requirements are also subject to design control requirements. This second edition of a bestselling book expands and updates all chapters with detail on current design control requirements, more examples, and further explanation and clarification of the requirements. The book also addresses device risk and classification, and covers risk management in its own chapter. Appendices have also been revised"--Provided by publisher.
650	1	2	_aEquipment Design _xstandards _zUnited States.
650	1	2	_aEquipment and Supplies _xstandards _zUnited States.
650	2	2	_aIndustry _xstandards _zUnited States.
650	2	2	_aQuality Control _zUnited States.
942			_2ddc _cLIBRO
999			_c1104