A malfunction can occur during improper exchange of the heart pump’s back-up system controller.
A vibration issue could cause the device to stop therapy.
Documentation proves compliance, including when it comes to acceptance activities.
The issue involves problems removing the balloon sheath during cardiac procedures.
The felony charges involve stealing confidential product information for use with a competitor.
The new commissioner was confirmed in a 57 to 42 vote.
Experts at hospitals state that they need clearer and more organized information from device manufacturers during a recall.
Failure to investigate complaints is a major compliance failure.
Recalls involving lithium-ion battery components are far more complex and if not handled properly, can have dangerous consequences.
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