Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.
Showing 12 of 292 articles · Page 14 of 25
Permissions vs Rights (Access Control) for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.
Read article
Medical Device Cybersecurity Risk Profiles for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.
Read article
Premarket Cybersecurity Insider Tips: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.
Read article
Medical devices using GSM face downgrade and interception risks. Learn practical mitigations: disable 2G, use TLS/mTLS, secure APNs, and FDA-ready.
Read article
The complete guide to NFC and RFID cybersecurity for FDA-regulated medical devices - vulnerabilities, threat modeling, test evidence, and §524B / SPDF.
Read article
Discover the critical role of Near Field Communication (NFC) in safeguarding medical devices from cyber threats. Aligned with the FDA's Feb 3, 2026 premarket.
Read article
GET vs POST explained: idempotency, caching, body size, and the security pitfalls, including how to choose correctly for medical device APIs.
Read article
The risks and vulnerabilities in M2M communication between connected medical devices, and the cybersecurity controls the FDA expects at premarket review.
Read article
IVD Regulation Cybersecurity for medical device manufacturers: what the FDA expects in 2026, gaps that trigger deficiencies, and evidence to prepare.
Read article
Discover how implementing a Secure Software Development Life Cycle (SSDLC) can significantly bolster cybersecurity measures for medical devices.
Read article
CAPA for medical devices explained: root cause analysis, corrective actions, FDA 21 CFR 820.100 alignment, and how cybersecurity findings feed CAPA under the Feb 3, 2026 guidance.
Read article
How 21 CFR Part 820 (and the 2026 QMSR update aligning it to ISO 13485) governs cybersecurity: design controls, CAPA, document controls, and Section 524B evidence.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.
