CE Marking of Medical Thermometer
Different types of Thermometers, Classification and Conformity assessment and routes for MDR CE Mark...
Substantial Equivalence
Substantial Equivalence is the demonstration that a new device, compared to a predicate device for t...
Covid 19 Emergency use Devices and FDA Registration and Listing Information
# Product Nature Product Code Approval 1 Surgical Face Mask Sterile / Non-Sterile FXX ...
Abbreviated 510k & Guidance
The medical devices for which the FDA 510k or premarket notification is required from the US FDA bef...