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Author: Nelson Labs





March 4, 2020

Testing in Flux: Changing Protocols for a Transformative Industry

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...

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February 20, 2020

Assessing Hemocompatibility for Medical Devices in Contact with Circulating Blood

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...

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February 18, 2020

Proceed with Caution: Medtech Seeks Safe Packaging and Sterilization Solutions

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...

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February 5, 2020

Testing 3D printed medical devices for biocompatibility

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...

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February 3, 2020

Chemistry for Toxicological Risk Assessment—Transitions in Expected Approach

FDA’s expectations regarding ChemTox will be discussed during an upcoming MD&M West 2020 presentation. One of the cornerstones of biocompatibility evaluations is the use of toxicological risk assessment to screen for potential hazards and safeguard against long-onset risks like cancer....

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