NAMSA's Davide E. Albert recently spoke at MD&M West. Among other topics, Albert discussed the importance of characterizing materials for medical devices. Characterization is the process that describes the nature of the materials. It includes chemical, toxicology, physical, mechanical, morphological, and electrical aspects of all materials used in devices. The process should be done, he expalined, not only as a matter of safety, but to optimize performance and reduce risks. In addition, proper characterization satisfies regulatory considerations and the data can be used throughout the product life cycle for  problem solving. Using EN ISO 10993-1 and ISO 14971 can help developers gain an understanding of the characterization needs, he said.