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
Based on a very insightful webinar in January, Regulatory Insights: The Future of MedTech and Pharma Under the New Administration, which was presented by a panel of two Nelson Labs experts and two Regulatory Compliance Associates (RCA) experts, RCA has...
As regulations and requirements around the world change, so too do the testing protocols for medical devices, sending OEMs to consult expert partners. Testing methods and approaches continue to be shaped by regulatory changes. At the end of 2019, the...
Have you considered the risks of hemolysis and thrombosis as well as the impact of any changes in manufacturing and processing parameters? Many commonly used medical devices, such as catheters, cardiopulmonary bypass systems, and endovascular grafts, are intended to come...
Concerns surrounding ethylene oxide have brought the packaging and sterilization segments to the forefront for medical device manufacturers. Packaging and sterilization services play a critical role in delivering a device to market and ensuring compliance with even the most stringent...
Matthew R. Jorgensen, PhD, DABT explains how 3D printed medical devices are tested for biocompatibility In this article, Matthew R. Jorgensen, PhD, DABT, Chemistry and Materials Scientist at Nelson Labs, explains how testing 3D printed medical devices verifies biocompatibility in an industry...
