State Of The Art FAQ
What does “state of the art” mean in the context of medical devices?
Why is it important? What do you need to do?
We answer these questions and more…
SoTA
State of the art
Clin-r+ wants to assist manufacturers to understand the state of the art and provides guidance to help explain what it is and how it can help make your CE submission successful.
State Of The Art Literature Reviews
Under MEDDEV 2.7/1 rev 4 regulations, literature reviews play an important role in several areas of the CER, including establishment of State of the Art (SOTA). The state of the art “describes what is currently and generally considered standard of care, or best practice, for the medical condition or treatment for which the device is used.”
