國立臺灣大學農藝學系Liu, Jen-PeiJen-PeiLiu2006-09-282018-07-112006-09-282018-07-112005-12-29http://ntur.lib.ntu.edu.tw//handle/246246/20060927123046398630The US PremarketRegulation PremarketApproval (PMA) PremarketNotification -510(k) De NovoReview –513(f)(2)application/pdf1305323 bytesapplication/pdfzh-TWMedical Devices Quality System Case Study: Biochip Productsotherhttp://ntur.lib.ntu.edu.tw/bitstream/246246/20060927123046398630/1/medical device.pdf