FDA Finalizes Medical Device Cybersecurity Premarket Guidance
The FDA has finalized guidance to assist medical device sponsors in addressing cybersecurity considerations as part of the premarket review process.
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Search Results for: cybersecurity
FDA Releases White Paper on Cybersecurity in Medical Manufacturing
New white paper highlights the need to secure operational technologies used in medical product production.
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VA Report Flags Ongoing Sterile Processing Failures at Georgia Facility
A March 2025 report details ongoing VA sterile processing failures at the Carl Vinson VA Medical Center, including the use of damaged surgical instruments.
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Why Smarter Infusion Pumps Demand Smarter Development
As technology advances, systems engineering offers a framework for reducing risk, improving performance, and enhancing patient outcomes.
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From Work Orders to Safety Signals: Elevating Medical Device Management in the CMMS
Rethinking medical device CMMS workflows can help HTM teams move beyond work order tracking to proactively identify and manage clinical safety risks.
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