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Can You Reduce Device Risk Just By Informing the User?

Over 20 years ago, a doctor phones a medical device company’s technical service group from nearly half a world away, and is in a panic. He’s performing his first implant of the newly available AICD [automated implantable cardioverter defibrillator] technology, and his patient is sedated, on the table and there is a problem. “I’ve implanted […]

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