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
Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows.
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...
ISO 10993-1 guides the biological evaluation of medical devices. With the Final Draft International Standard (FDIS) approved, this update is one of the most significant in recent years. The panel covered what is changing and how to prepare. This FAQ...
This article by biocompatibility experts Helin Räägel and Thor Rollins discusses the major upcoming revision of ISO 10993-1. Read the Full Article in MD+DI Learn more about the authors below.
“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...
