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
QARA ISO 14971, Biocompatibility Testing, MDR CE MARKING June 22, 2020 CMR or Endocrine Disrupting Substances in the Medical Devices ... Read More
QARA MDR CE MARKING, Biocompatibility Testing June 18, 2020 Medical Devices Incorporating Nano materials According to EU directive 2011/696/EU, the definition of Nano material is redefined in the MDR as â€... Read More
QARA MDR CE MARKING June 18, 2020 Medical Device Composed of Substances Medical devices composed of substances or combination of substances intended to be introduced to the... Read More
QARA ISO 13485, MDR CE MARKING June 17, 2020 Critical Processes in the Medical Device Manufacturing Critical Processes in the Medical Device Manufacturing The manufacturing of the medical devices shou... Read More
QARA MDR CE MARKING June 17, 2020 Preclinical Data of Medical Device The preclinical medical device testing is conducted to determine the performance and safety based on... Read More
QARA MDR CE MARKING June 16, 2020 Electromagnetic Compatibility of Medical Devices Electromagnetic Compatibility of Medical Devices For active medical devices CE marking, it is... Read More