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 to establish procedures to ensure that the design requirements are appropriate and address the intended use of the device, including the needs of the user and patient. These procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements.
