FDA Releases Final Guidance for Reprocessing Medical Devices on Mar. 17, 2015

The FDA has finalized the long awaited guidance document, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” on March 17, 2015 following the draft of the document which was issued on May 2, 2011. While the majority of changes made include minor rewording, additional reference to resources, and expansion upon topics to provide clarity, there is a notable emphasis placed on device design and reprocessing of complex devices. Read more

LexaMed Expands Chemistry Capabilities

LexaMed has recently upgraded its in-house chemistry capabilities to better serve our clients’ needs. The upgrades include expanded GC capabilities, HPLC developmental work and stability testing capabilities, UV analysis for selected compounds and protein, and carbohydrate and hemoglobin analysis in support of cleaning studies. We have experienced chemists available Read more