All medical devices have risk. “You, as the manufacturer, are responsible for determining the risk of your medical device and if that risk is acceptable,” said Joseph Tartal, FDA deputy director in ...
No medical device is without risk. And, in the manufacture of medical devices, risk management cannot be taken seriously enough. Failures can have far reaching impacts on the health and safety of ...
These definitions as written out by AAMI (The Association for the Advancement of Medical Instrumentation) offer clarity, helping designers recognize and address these risks effectively in product ...
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