eProgesa is now cleared under the 510(k) process, including for cloud hosting with MAK.Care

We are thrilled to share our BECS, eProgesa, is now 510k cleared from the FDA, including for cloud hosting with our MAK.Care service.!

On 3rd November FDA informed us that our blood establishment computer system ePROGESA v5.0.3, is cleared under the 510(k) regulatory pathway and can be promoted and sold in the U.S. This 510(k) clearance establishes the foundation to further enable the ePROGESA initiative on the AWS cloud.

Since our last ePROGESA 510(k) clearance several functional and technical changes have occurred since then with one of the most recent being hosting ePROGESA on the cloud, in addition to the traditional on-prem option.

MAK is proud that with the support of our clients we can demonstrate that ePROGESA is safe and effective, both on-prem and on-cloud.

eProgesa 510k cleared from the FDA