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eMDR Rule Could Hurt Device Companies

December 8, 2009
A proposed rule requiring device manufacturers to submit all medical device reports (MDRs) electronically could hurt both multinational and small companies, industry says. Full compliance with the rule as proposed in August is expected to cost the device industry between $58 million and $80 million, Brett Berty, a senior strategist for device recalls at Stericycle ExpertRecall, a Lake Forest, Ill., consulting firm, said.
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