Every article in our archive tagged PCCP.
Looking for a quick answer instead? The FDA medical device cybersecurity FAQ covers Section 524B scope, SBOMs, threat models, CR515 and GMLP, deficiencies, and postmarket duties.
Showing 4 of 4 articles tagged PCCP
Threat modeling AI-enabled medical devices: how to add the model, training pipeline, and updates to your threat model, with a worked example of a fictional AI dosing advisor.
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AI training data security for medical devices: how to track where data comes from, control who can change it, and show the FDA your training pipeline is protected.
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AI model integrity for medical devices: how to stop model files from being stolen or swapped, sign model updates, and show the FDA the model that runs is the one you validated.
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The FDA PCCP guidance isn't AI-only. Use a predetermined change control plan for cybersecurity patches, firmware updates, and SBOM component swaps.
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