Impending European regulations on medical testing have medical device makers around the world hopping. The European Union is expected to implement its In Vitro Diagnostics (IVD) Directive by December 2003. It will require calibration of medical devices for measuring specific substances in IVD samples, such as cholesterol or glucose, to be traceable to a national standard. Manufacturers will have to comply with the regulations in order to do business in EU member countries. Stakeholders worldwide recently gathered in Gaithersburg, MD, to discuss how to meet the EU directive. The U.S. National Institute of Standards and Technology, meanwhile, is developing a database of reference materials that the IV industry can use. The database will serve as a benchmark for developing individual diagnostic tests for IV samples. E-mail email@example.com.
Producing high-quality end-production metal parts with additive manufacturing for applications like aerospace and medical requires very tightly controlled processes and materials. New standards and guidelines for machines and processes, materials, and printed parts are underway from bodies such as ASTM International.
Engineers at the University of San Diego’s Jacobs School of Engineering have designed biobatteries on commercial tattoo paper, with an anode and cathode screen-printed on and modified to harvest energy from lactate in a person’s sweat.
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