Sabratek Corp. 8/19/98 Infusion pumps 1. Failure to identify the actions needed to correct and prevent recurrence of non-conforming product. For example, it was determined that the _____ had a software problem which prevented the infusion rate from exceeding the bolus rate while operating in the “PCA” mode. While the software has been revised, the...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.