29
Oct
1998

ICS Medical Diagnostic opthalmic devices

0

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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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