Constructing Safety Assurance Cases for Medical

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Constructing Safety Assurance Cases for Medical Devices Arnab Ray, PhD Senior Research Scientist Fraunhofer USA Center for Experimental Software Engineering Rance Cleaveland, PhD Professor, Department of Computer Science University of

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01
Constructing Safety Assurance Cases for Medical Devices Arnab Ray, PhD
Senior Research Scientist
Fraunhofer USA Center for Experimental Software Engineering Rance Cleaveland, PhD Professor,
Department of Computer Science
University of Maryland<br>
02
The Food And Drug Administration Federal body charged with the responsibility of “protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation” 2<br>
03
The Regulatory Process 3 510(k): device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA)
PMA: Approval based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses<br>