Traditional 510k
The Traditional 510k is one of the three types of the 510k in the US FDA. This type of 510k [&hellip...
Medical Devices Incorporating Nano materials
According to EU directive 2011/696/EU, the definition of Nano material is redefined in the MDR as â€...
Medical Device Composed of Substances
Medical devices composed of substances or combination of substances intended to be introduced to the...
Critical Processes in the Medical Device Manufacturing
Critical Processes in the Medical Device Manufacturing The manufacturing of the medical devices shou...
Preclinical Data of Medical Device
The preclinical medical device testing is conducted to determine the performance and safety based on...