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Scandinavian Journal of Clinical and Laboratory Investigation Volume 59, 1999 - Issue 7
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Research Article

Development and use of analytical quality specifications in the in vitro diagnostics medical device industry

D. M. Powers One Wandering Trail, Pittsford, 14534 USA
&
N. Greenberg One Wandering Trail, Pittsford, 14534 USA
Pages 539-543 | Published online: 08 Jul 2009

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Manoj Sivan, Justin Gallagher, Ray Holt, Andy Weightman, Martin Levesley & Bipin Bhakta. (2014) Investigating the International Classification of Functioning, Disability, and Health (ICF) Framework to Capture User Needs in the Concept Stage of Rehabilitation Technology Development. Assistive Technology 26:3, pages 164-173.
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Articles from other publishers (7)

María Vaquero Martín, Ronny Reinhardt & Sebastian Gurtner. (2016) Stakeholder integration in new product development: a systematic analysis of drivers and firm capabilities. R&D Management 46:S3, pages 1095-1112.
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Syed Ghulam Sarwar Shah & Ian Robinson. (2007) Benefits of and barriers to involving users in medical device technology development and evaluation. International Journal of Technology Assessment in Health Care 23:1, pages 131-137.
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Syed Ghulam Sarwar Shah & Ian Robinson. (2006) User involvement in healthcare technology development and assessment. International Journal of Health Care Quality Assurance 19:6, pages 500-515.
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M. Panteghini & J.C. Forest. (2005) Standardization in laboratory medicine: New challenges. Clinica Chimica Acta 355:1-2, pages 1-12.
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Franca Pagani, Francesca Stefini, Jean-Paul Chapelle, Guillaume Lefèvre, Hanafi Graı̈ne, Hilmar Luthe, Jutta Engelmayer & Mauro Panteghini. (2004) Multicenter evaluation of analytical performance of the Liaison® troponin I assay. Clinical Biochemistry 37:9, pages 750-757.
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Nada Majkic-Singh. (2004) CE lebel and harmonisation of quality systems in medical laboratories. Jugoslovenska medicinska biohemija Yugoslav Medical Biochemistry 23:1, pages 77-83.
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Jacqueline Bremond & Mario Plebani. (2001) IVD industry role for quality and accreditation in medical laboratories. Clinica Chimica Acta 309:2, pages 167-171.
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