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PLM tames FDA tasks

The Medical Device Template inside Windchill PDMLink from PTC Inc., Needham, Mass., (ptc.com ) let a medical-device maker trace and record product data over entire product lifecycles. Doing so is required by the FDA and foreign regulatory agencies before a company can sell products in their countries. “The template lets us see more product-development details, especially when it comes to coordinating mechanical, electronics, and software design,” says Klaus Welte, VP of R&D at Stryker Navigation Corp., Germany, (stryker.com). “What's more, the software reduces the number of modifications caused by out-of-date design information from different sources. We expect to see an ROI within the first year.”

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© 2012 Penton Media Inc.


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