Every article in our archive in Fundamentals.
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 8 of 44 articles in Fundamentals · Page 4 of 4
A practitioner build plan for medical device cybersecurity: what FDA reviewers ask for, what evidence satisfies SW96, SBOM, and testing, and what it costs.
Read article
Medical Device Cybersecurity Inventory for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.
Read article
Why IDS/IPS agents don’t work for medical devices and what FDA-aligned alternatives like segmentation, gateways, and monitoring mean for patient safety.
Read article
Medical device cybersecurity for MedTech executives: what it costs, when to fund it, what Section 524B exposes you to, and what a missed postmarket plan costs.
Read article
What MedJacking and MedHacking actually describe, which cases are verified, and the controls that break the attack chain on fielded devices.
Read article
Updated July 24, 2026 Health Level 7 (HL7) is a vital cog in the machinery of healthcare information technology. Aligned with the FDA's Feb 3, 2026.
Read article
The top 10 medical devices most exposed to cyber attacks, why each is vulnerable, and the cybersecurity controls manufacturers should apply before submission.
Read article
Explore real-world examples of hacked medical devices, understanding the patient risks and critical need for enhanced cybersecurity controls in healthcare.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've shipped 275+ devices supported.
