FDA 510k Biocompatibility Assessment
* In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen...
How to CE Mark your Medical Devices and Avoid Problems!
* In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen...
CE Marking of Medical Thermometer
Different types of Thermometers, Classification and Conformity assessment and routes for MDR CE Mark...
Medical Device Post Market Surveillance
Medical Device Post Market Surveillance is normally performed after the medical device is released i...
Clinical Evaluation and Technical Documentation
Clinical Evaluation and Technical Documentation are interrelated in medical devices MDR compliance a...