Every article in our archive in Fundamentals.
Showing 12 of 55 articles in Fundamentals · Page 4 of 5
Understand Software as a Medical Device (SaMD), its regulations, types, and impact on healthcare. Learn how SaMD aids diagnosis, treatment, and monitoring.
Read article
Relevant Threats to Medical Devices for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.
Read article
How powerShell Attacks target medical devices, real-world examples, and the controls FDA expects manufacturers to implement in 2026.
Read article
Learn what return-to-libc attacks mean for medical device cybersecurity-and how to reduce risk with memory protections, secure coding, and testing.
Read article
Discover how cybersecurity failures in medical devices have led to recalls and potential risks for patients. Aligned with the FDA's Feb 3, 2026 premarket.
Read article
Utilize our medical device cybersecurity assessment checklist designed for manufacturers, developers, and healthcare organizations to secure devices.
Read article
Discover cybersecurity best practices for medical device design, from threat modeling to FDA-aligned lifecycle management, to protect patients and data.
Read article
Emerging technologies significantly expand the attack surface for medical devices. Learn how digital health, AI, ML, and IoT introduce vulnerabilities.
Read article
The 12 medical device cybersecurity best practices FDA reviewers expect in 2026: SW96 threat modeling, SBOM with VEX, pen testing, secure updates, and 524B evidence.
Read article
Stop SQL injection (CWE-89) in medical device software using parameterized queries, testing, and FDA-aligned secure development evidence. Aligned with the.
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 article30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.
