International standards organizations have adopted a new cybersecurity standard for medical devices that goes beyond just looking at a product’s risk level as required by the US Food and Drug Administration, say attorneys at King and Spalding.
Experts: New Cybersecurity Standard Goes Beyond What US And Other Regulators Require
A recently published international cybersecurity standard goes beyond what regulators currently require of medtech manufacturers, say attorneys at King and Spalding. If adopted by the US FDA and others, it could add significant burden on medical software developers.
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