EU MDR Rule 11 Classification for SaMD & CE Mark Process
In this blog, we have explained the EU MDR Rule 11 classification for SaMD. Additionally, we have detailed the CE mark certification process for SaMD. What is SaMD? Software as a Medical Device (SaMD) refers to standalone software that has a medical purpose on its...
CE Marking of Digital Health Technologies: EU MDR Guidelines
Digital health technology is the integration of digital tools into healthcare to improve prevention, diagnosis, monitoring, and treatment. CE marking of digital health technologies is mandatory under the EU Medical Device Regulation (MDR). It ensures that software,...
CE Marking for Ophthalmic Medical Devices
Ophthalmic medical devices are specialized instruments and equipment used to diagnose, monitor, and treat eye conditions. These devices range from simple diagnostic tools to advanced therapeutic and surgical products. CE marking is critical for ophthalmic medical...