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Medical Device Security: Achieving Regulatory Approval

Regulators around the world are taking a larger and larger role in requiring and verifying that devices are as secure as possible both before and after release. In the United States, the Food and Drug Administration (FDA) has published guidance that outlines requirements for medical devices that mandate a number of facets of device development and maintenance (the European Union, Japan and other countries have published similar guidance, so this paper will focus on the FDA).



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Siemens Digital Industries Software

T (800) 498-5351

Address
5800 Granite Parkway, Suite 600, Plano, TX, 75024, United States
View map

 
 

Siemens Digital Industries Software

T (800) 498-5351

Address
5800 Granite Parkway, Suite 600, Plano, TX, 75024, United States
View map