Cybersecurity is no longer just an IT or privacy issue. For FDA regulated companies, it’s a patient safety issue, a product quality issue, and increasingly a regulatory enforcement issue. FDA has made it clear that cybersecurity vulnerabilities can affect medical devices, software, manufacturing operations, clinical data, and even the availability of life saving products.
Today, we’re bringing together two perspectives—the FDA regulatory lens and the cybersecurity lens—to talk about what companies need to understand and where they’re getting tripped up.
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