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Helping Start-Ups Avoid Slow-Downs
Date:6/28/2012

RESTON, Va., June 28, 2012 /PRNewswire/ -- For U.S.-based medical device start-ups, speed to global markets is often the most pressing concern, but trying to move too fast often leads to preventable mistakes that could take the CE Marking process back to the drawing board, according to healthcare experts at BSI Group America, a leading Notified Body that helps companies comply with the essential regulatory requirements of the European Union.

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CE Marking on a product ensures the free movement of the product within the European Free Trade Association and European single market that totals 30 countries, giving manufactures a wealth of global opportunities. The best way to avoid snags in the approval process, says Paul Brooks, SVP for BSI Healthcare Solutions, is to learn from the mistakes made by companies who have previously gone through the process.

"Everyone makes mistakes, but in the medical device industry, a mistake can set a manufacturer back months or years and often millions of dollars," said Brooks. "It's best to learn from others' mistakes and get it right the first time."

To help new medical device companies do just that, Brooks has identified the following seven "rookie mistakes" typically made by medical device start-ups.

  1. Assuming regulatory clearance in the U.S. is a gateway to CE Marking in Europe.
    Medical devices in the EU are governed by one of three Medical Device Directives (MDD, AIMD, IVDD). While going through the FDA's process might help in a manufacturer's ability to present technical data for review, previous FDA regulatory clearance plays no part in the CE Mark certification decision.
  2. Your product does not fit the definition of a medical device in the EU.
    European medical device Directives are very specific about what they consider to be "
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SOURCE BSI Group America Inc.
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