QARA MDR CE MARKING February 12, 2021 Sampling Plan The sampling criteria: The main sampling criteria are lot sizes, inspection levels, acceptable qua... Read More
QARA FDA 510k July 30, 2020 Substantial Equivalence Substantial Equivalence is the demonstration that a new device, compared to a predicate device for t... Read More
QARA FDA 510k June 25, 2020 Abbreviated 510k & Guidance The medical devices for which the FDA 510k or premarket notification is required from the US FDA bef... Read More
QARA FDA 510k June 24, 2020 Traditional 510k The Traditional 510k is one of the three types of the 510k in the US FDA. This type of 510k [&hellip... Read More