Today’s regulatory environment requires top-notch partners to help navigate preclinical testing. With that in mind, WuXi AppTec is very excited to announce the return of Dr. Sherry Parker! Dr....
Preparing for MDR: Don’t Forget about Class I Reusable Devices
Medical device manufacturers are busy preparing for the about MDR and Class III device changes. As you work through your portfolio and sort your products into families, you’ll face many tough...
Poor Extraction Methods Can Impact Study Results
When planning a cleaning validation study for your medical device, a validated extraction method is one requirement.
The purpose of an extraction process is to recover any residual soils from the...
Cleaning Validations and Process Robustness: How to Build a Study Design
The process of cleaning medical devices, either in healthcare settings or at a third-party manufacturer, includes many operational steps and variables. To prove the robustness of process design...
Important to Address the Stacked Effects of Soil Accumulation on Medical Devices
After each use of a medical device, soil may accumulate at a microscopic or macroscopic level that could potentially impede the terminal disinfection or sterilization process.
Over the course of a...