Posts by Russell Haley

Russell Haley

Overview of the New FDA Guidance on Cybersecurity

“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA” is a new document produced by the FDA that provides guidance on integrating cybersecurity into the quality system management and premarket submission process for medical devices. It covers risk management, design controls, software validation, and other elements to ensure the safety, […]

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