The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
This eBook addresses common challenges and best practices for medical-device manufacturers with questions about testing their products. Table of Contents: EO Optimization and Potential Effects on Sterile-Barrier Packaging Patient-Specific Implants Often Require More Testing Extractable Chemical Characterization and Risk Assessment:...
On May 20, 2021, FDA published a document (“Safety of Metals and Other Materials Used in Medical Devices”) requesting input regarding the best methods to use in conveyance of material information for a broader range of medical devices to both...
