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
Biocompatibility is often treated as a milestone, a box to check on the path to regulatory approval. In reality, it is the cumulative outcome of hundreds of decisions made long before a device ever reaches a test lab. Every choice...
The use life of an orthopedic medical device can vary greatly depending on multiple factors, including its purpose, where it’s used, and whether it remains in the body. These factors can affect numerous aspects of the device’s development, as well...
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 Final Draft International Standard (FDIS) of ISO 10993-1 introduces the most significant updates in decades to the biological evaluation of medical devices. Among other things, these revisions reinforce a risk-based framework aligned with ISO 14971, expand expectations for particulate...
Even small modifications to a medical device, whether materials, processes, or sterilization methods can significantly affect its biological safety. This whitepaper provides a risk-based framework, grounded in ISO 10993-1 and ISO 14971, for evaluating when and how to reassess biocompatibility...
