USE error and medical device recall

Posted on August 2, 2020August 2, 2020 by admin

FDA’s definition of USE error though the word USE error is not used officially. “Act or omission of an act that results in a different outcome than intended by the manufacturer or expected by the USER, which may result from a mismatch situation between USER, man-machine interface, task and/or environment.” AAMI HE74:2001 Many research suggests Read more about USE error and medical device recall[…]

Basics of Japanese Medical Device GCP (JGCP)

Posted on July 30, 2020July 30, 2020 by admin

JPAL Laws, Ordinances and Notifications (relevant to GCP audits & the foreign manufacturer) The Pharmaceutical Affairs Law (Law No. 145 Established as of August 10, 1960; Law No. 87 Revised as of July 26, 2005)MHLW Ministerial Ordinance No. 36 Clinical Tests for Medical Devices (hereinafter referred to as “Medical Device GCP” or “JGCP”)YAKUSHOKUKIHATSU No. 0720005 Read more about Basics of Japanese Medical Device GCP (JGCP)[…]