Thursday, October 11, 2012 4:24 PMOr more general, can Microsoft commercial OS be used for class III medical device?
Thursday, October 11, 2012 7:18 PM
I forget the different classes, but if the device keeps the patient alive, then NO!
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Friday, February 01, 2013 3:55 AM
Full details are presented by the FDA:
Class I =>devices are defined as non-life sustaining. These products are the least complicated and their failure poses little risk.
Class II =>devices are more complicated and present more risk than Class I, though are also non-life sustaining. They are also subject to any specific performance standards.
Class III =>devices sustain or support life, so that their failure is life threatening.
Microsoft not suggestion using embedded OS to development for FDA class III.
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