8 – Product development overview
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[1] Daniel Drucker,et al. Implications of the New Food and Drug Administration Draft Guidance on Human Factors Engineering for Diabetes Device Manufacturers , 2012, Journal of diabetes science and technology.
[2] Wu Jun-hua. Introduction of ISO/TR 14969:2004 Medical devices-Quality management systems-Guidance on the application of YY/T0287-2003 , 2005 .