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.
As manufacturers add new technologies to their products, designing for compliance becomes more difficult. Prepare for the certification testing process. Otherwise, you increase the risk of discovering a safety issue after a product leaves the assembly line. That will cause significant time-to-market delays, be much costlier to fix, and damage your brand in the eyes of customers.
Stratasys will be exhibiting two groundbreaking large-scale additive manufacturing technologies, as well as other new products, next month at the International Manufacturing Technology Show (IMTS) in Chicago.
Two new technologies from Stratasys, created in partnership with Boeing, Ford, and Siemens, will bring accurate, repeatable manufacturing of very large thermoplastic end products, and much bigger composite parts, onto the factory floor for industries including automotive and aerospace.
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