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
Medical devices must be proven safe and effective under all conditions of use, making a well-designed, device-specific test plan essential. These plans consider factors such as intended use, transport, environment, and end users to ensure reliable performance. In this Q&A,...
“The MDR requires manufacturers to submit significantly more documentation covering the total product lifecycle than previously under the MDD. A critical change with MDR is the clinical evidence necessary to demonstrate the safety and efficacy of the device… Manufacturers must...
