Villa Sistemi Medicali, S.p.A. 9/30/98 Dental x-ray systems Failure to maintain Device Master Records (DMR) that includes or refers to the location of: device specifications including component specifications, software specifications; production process specifications; quality assurance procedures; and labeling specifications as required by 21 CFR 820.181(a)(b)(c) and (d). For example, the firm has no Device Master...Read More

ICS Medical 10/29/98 Diagnostic opthalmic devices 1. Failure to develop, monitor, and control the software development processes to ensure that the software used in _____ conforms to its original design or any approved changes. 2. Failure to review the software development process to identify actions needed to prevent the recurrence of software nonconformances. 3. Failure...Read More