Medical device cybersecurity, explained clearly.

October 28, 2026

Topics: FDA Cybersecurity Readiness, +3 more

Cybersecurity in FDA CDRH's proposed guidance list for fiscal year 2027

FDA's FY2027 guidance list finally includes a postmarket cybersecurity draft. What's on it, what it means for device makers, and what to do before Nov 30.

October 26, 2026

IVD Cybersecurity in the QMSR Era: What FDA's Warning Letters Are Signaling

The Association of Medical Diagnostics Manufacturers (AMDM) recently held its 2026 Focus Meeting, two days of regulatory updates for the IVD and diagnostics community…

October 22, 2026

Topics: FDA Cybersecurity Readiness, +6 more

Cleared or Refused: What Gets Medical Devices Through FDA's Cybersecurity Review

Picture three medical device companies sending FDA their applications to go to market. Each has a real cybersecurity program, with policies and procedures, testing and…

October 22, 2026

Topics: Thought Leadership, +5 more

What We Heard in Boston: Notes from the 2026 US Medical Device Cybersecurity Conference

Less debate about the rules. More questions about execution and proof. We spent last week in Boston at TT LifeSciences’ US Medical Device Cybersecurity Conference. Axel ran a…

October 22, 2026

Topics: FDA Cybersecurity Readiness, +5 more

CVSS for Medical Device Product Risk: Flawed, but Still Essential

If you have a hammer, everything is a nail Bottom line CVSS is flawed, and everyone in the field knows it. But it’s the tool that security professionals rely on and medical device…

October 21, 2026

Topics: Regulatory, +2 more

GenAI Devices Don't Need New Security Rules — They Need FDA's Existing Ones

FDA's discussion paper on generative AI-enabled medical devices gets a lot right, including calling for testing against prompt injection and adversarial prompting. But it treats…

August 19, 2026

Topics: Thought Leadership

Five Years Later: What Our 2021 Healthcare Cybersecurity Constraints Look Like Today

In March 2021, Medcrypt published “Why Healthcare Cybersecurity Is Hard,” written by Seth Carmody, arguing that healthcare’s cybersecurity problem was never primarily a technology…

August 10, 2026

Topics: Tools & Processes, +5 more

Case Study: Precision in Practice- How Helm Redefines SBOM Vulnerability Management

Introduction Helm, developed by Medcrypt, emerges as a robust and precise SBOM (Software Bill of Materials) and Vulnerability Management Tool tailored to identify potential…

August 10, 2026

Topics: Thought Leadership, +3 more

Part 2: HHS Wall of Shame Analysis 2009–2023 — Changing Regulatory Environment

As we demonstrated in Part 1 of this blog as well as reported in public media through the coverage of individual security events ( domestic and international ), healthcare…