Software as a Medical Device (SaaMD)

Software becomes a Medical Device if it is used to provide Diagnostic Data. One example is the RDT Reader System, which is able to read Test Results from Test Kits.

Where SaaMD differs from SaaS, for example, is that when Software is used as a Medical Device it becomes subject to FDA approval. SaaMDs can be approved via 510(k).

Because at Open Ecosystems we group our Software in Systems, “SaaMD” could also be read as “System as a Medical Device”.