Clinical Validation of SaMD: Vital for Clinical Relevance
Software as a Medical Device (SaMD) is a software intended to be used for medical purposes without being part of a physical medical device. It can perform functions, such as diagnosing, preventing, monitoring, or treating diseases, by analyzing data and providing...
Quality Management System for SaMD: Focus Areas & Principles
Software as a Medical Device (SaMD) refers to a software that is intended to be used for medical purposes. SaMDs are not part of a physical medical device. The software itself is regulated as a medical device, even though it runs independently on computers,...
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...