Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.
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 12 of 248 articles · Page 1 of 21
PreSTAR vs eSTAR explained: PreSTAR is the voluntary FDA template for Q-Submissions, eSTAR is required for 510(k) and De Novo. How cybersecurity carries across.
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Medical device cybersecurity at each study stage: rodent, large animal, primate, and human trials, and what the FDA expects before your IDE and marketing submission.
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What a medical device security advisor does after FDA clearance: keeping the threat model and SBOM current, rating vulnerabilities, and answering hospitals.
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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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Hospital security questions for AI medical devices: what reviewers ask about models, patient data, outside AI services, and updates, and how to answer with evidence.
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What investors ask medical device founders about cybersecurity during a raise, what good answers look like, and how to prepare a diligence-ready package.
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Medical device data sovereignty explained: where patient data lives, what HIPAA and GDPR transfer rules require, and how to answer hospital security questionnaires.
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Generative AI medical device security: how prompt injection, data leakage, and unsafe outputs threaten LLM features in devices, and the controls and tests the FDA will look for.
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Cybersecurity hazard analysis for medical devices: how to turn confidentiality, integrity, and availability losses into hazards, harms, and risk controls in your ISO 14971 file.
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DICOM fuzzing for medical devices: which parts of the protocol and file format to fuzz, how to prove a real crash, and what evidence the FDA expects.
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