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:...
According to ISO 10993-1:2018, “the biological evaluation of any material or medical device intended for use in humans shall form part of a structured biological evaluation plan within a risk management process in accordance with ISO 14971.” Based on the...
