JavaScript Static Analysis Tools for Medical Devices White Paper - Ketryx Compliance Framework

JavaScript Static Analysis Tools for Medical Devices

The focus of this paper is on software applications written in JavaScript that meet the Food and Drug Administration’s (FDA) regulatory definition of a medical device.

The focus of this paper is on software applications (Apps) written in Javascript that meet the Food and Drug Administration’s (FDA) regulatory definition of a medical device. Because medical devices are used to treat, diagnose, deliver therapy, etc. their use may result in patient harm, ranging from minor injuries to death. Therefore, freedom from unacceptable risk (safety) is an imperative, and security is a subset of safety.

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