May 28 - 5:33
The US FDA announced the launch of a pilot regulatory project related to the “Software as a Medical Device” (SaMD) in the course of amendments to the medical devices certification rules. 2019 Test Plan The...
May 24 - 5:43
Medical devices in Italy are subject to the same regulations as all countries in the European Union (EU) which were implemented in 2017. Here, you can find out more information on the EU MDR and IVDR regulation....
May 22 - 5:49
The Saudi medical regulating authority announced upcoming changes in their medical device regulations. These changes are occurring with the goal to harmonize regulatory requirements with those of the European Union,...
May 21 - 5:53
The US medical device regulating authority, the FDA, issued a Safety Communication on medical devices used for monitoring glucose levels. These devices are primarily used by patients with a high risk for diabetes. The...
May 17 - 4:59
Ireland medical device regulations are unified with other European Union countries and follow the same EU MDR and IVDR regulation. However, each country has their own Regulatory Authority (RA). In the case of Ireland,...
