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Stanford researchers publish review of US medical device regulation
Date:1/10/2008

sign, testing, manufacturing and post-market surveillance of medical devices.

  • Manufacturers have specific timeframes in which to report adverse events: five calendar days for device-related death, serious injury or malfunction requiring immediate action; 30 days if no immediate action is required.

  • The medical device reporting system is in the process of being improved through the development of electronic reporting tools, making it easier for manufacturers to relay potential problems.

  • Increased harmonization of international standards between the U.S., the European Union, Australia, Brazil and Canada are intended to improve the integration of medical device product safety and process quality on a global basis.


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Contact: Michael Stewart
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InHealth: The Institute for Health Technology Studies
Source:Eurekalert

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