1999
DOI: 10.1080/00365519950185319
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Development and use of analytical quality specifications in the in vitro diagnostics medical device industry

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Cited by 12 publications
(8 citation statements)
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“…Clin. The design control loop is not closed until the finished in vitro diagnostic system is adequately validated to meet the customer needs, including the laboratory's analytical quality specifications (9). are listed in the Cumulative Index, which appeared in connection with the contents of this journal Volume 27, 1989 says should be considered for clinical use.…”
Section: Introductionmentioning
confidence: 99%
“…Clin. The design control loop is not closed until the finished in vitro diagnostic system is adequately validated to meet the customer needs, including the laboratory's analytical quality specifications (9). are listed in the Cumulative Index, which appeared in connection with the contents of this journal Volume 27, 1989 says should be considered for clinical use.…”
Section: Introductionmentioning
confidence: 99%
“…In the case of medical devices, directives of organizations such as the FDA and the European Commission request user need analyses, human factors engineering or field trials (Patel et al, ; Money et al, ; Ratcliffe, ; Martin and Barnett, ; Schaeffer, ). These requirements are higher for firms that follow industrial standards such as those of the International Organization for Standardization (ISO) or the International Electrotechnical Commission (IEC) (Powers and Greenberg, ; Money et al, ). Additional requirements for user integration might be mandated by other entities, mainly as a prerequisite for obtaining funding or grants for development (Davey et al, ; Martin and Barnett, ; Martin et al, ).…”
Section: Resultsmentioning
confidence: 99%
“…The resultant designs are used to develop medical devices that have higher market usability (Gould and Lewis, 1985), improved equipment safety and efficiency (Lin, 1998) and may be successfully used and maintained (Fouladinejad and Roberts, 1996). Another reason for the higher user involvement at design stage is the requirement of formal design processes that should begin and finish with customer needs under regulation such as ISO 9001 (Powers and Greenberg, 1999). Nevertheless, each stage of the medical device technology lifecycle is important and user input during each stage of the medical device lifecycle would be definitely important and required.…”
Section: Identified Threementioning
confidence: 99%