letsdothis747Mar 202 minQuality Beyond Compliance - Making Quality Part of Your Way of LifeBy Mark Swanson, QRx Partner There has been some discussion around the amendment published in several of the ISO management system...
letsdothis747Dec 21, 20232 minIs the FDA Really Replacing the QS Reg??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...
letsdothis747Nov 28, 20235 minImproving Compliance and Effectiveness Through Leaner DocumentationBy Steve Gompertz, QRx Partner I recently talked about this subject at the Masters Summit 2023 in Salt Lake City. For anyone who couldn't...
letsdothis747Sep 14, 20231 minUPDATE: NEW FDA DRAFT GUIDANCES FOR 510(k) PRODUCTSBy: Mark Swanson, QRxPartner Planning to contact the FDA to get your product cleared?!? This process is often like looking through a...