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Medical device security: achieving regulatory approval

Examining medical regulatory requirements and how they affect embedded device design and testing

Reading time: 10 minutes

Embedded medical devices

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).

This paper discusses multiple topics that should be considered when attempting to meet the requirements of these recommendations.

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