By: Steve Gompertz, QRx Partner If you work in Medical Devices, you should already know that the FDA’s regulation 21 CFR Part 820 has...

By Steve Gompertz, QRx Partner As a consulting firm we get courted frequently by eQMS vendors who hope we will introduce our clients to...

By Mark Swanson, QRx Partner There has been some discussion around the amendment published in several of the ISO management system...

By: Mark Swanson, QRx Partner As we wind down in 2023, many people still hope that the final rule for the US Quality Management System...