Medical-device cybersecurity regulations, threat modeling, SBOMs, vulnerability monitoring, and more
FeaturedArticleCybersecurity
This article provides an in-depth exploration of medical device cybersecurity requirements, including best practices and FAQs. It also includes examples and resources for those ...
J. David Giese
FeaturedArticleAI/ML
AI-assisted medical device development is FDA-compliant when done right. The obstacle isn’t regulation. It’s the messy codebase you’ve been ignoring.
Yujan Shrestha
FeaturedArticleCybersecurity
Practical suggestions and tips for authoring SBOMs for medical devices and for using them to monitor for cybersecurity vulnerabilities.
J. David Giese
ArticleAI/ML
From solo clinicians prototyping algorithms to enterprise teams shipping production software, tools like Cursor, Claude Code, ChatGPT Codex, GitHub Copilot, Lovable, Replit, Ant...
Yujan Shrestha
ArticleCybersecurity
Does FDA require software escrow for SaMD? Not necessarily. Learn when escrow helps manage closed-source vendor risk, plus what to include and verify in deposits.
J. David Giese
GuidanceCybersecurity
The 2026 FDA guidance on medical device cybersecurity, updated to align cybersecurity expectations with the Quality Management System Regulation (QMSR) and ISO 13485.
ArticleAI/ML
A client called out the “consultant thing”: hiding behind “ideally” instead of recommending a real plan. This piece explains why ideal talk wastes time, how to anchor on constra...
Yujan Shrestha
ArticleAI/ML
Most first-time teams burn over a year overbuilding documentation FDA never asks for. Here is a section-by-section breakdown of a cleared AI/ML SaMD 510(k) (Body Check CT Cardio...
Yujan Shrestha
ArticleCybersecurity
In this article, we share a nuanced approach to avoiding sharing sensitive information in an SBOM.
J. David Giese
VideoCybersecurity
The conversation between Yujan Shrestha and J. David Giese focuses on making threat modeling more approachable and less intimidating. They share personal anecdotes to illustrate...
Yujan Shrestha & J. David Giese
VideoCybersecurity
We discuss challenges in medical device cybersecurity, including balancing FDA guidelines with practical hospital and manufacturer needs. They highlight risks like network vulne...
Yujan Shrestha & J. David Giese
ArticleCybersecurity
A survey that should give you a feeling as to whether you’re cybersecurity documentation is ready for an FDA marketing submission.
J. David Giese
ArticleCybersecurity
How do you avoid slowing down your FDA marketing submission (510(k), De Novo, or PMA) with cybersecurity problems? This article reviews 14 common FDA cybersecurity deficiencies ...
Yujan Shrestha & George Hattub
ArticleCybersecurity
A technical exploration and discussion of DICOM Part 15 Security
ArticleCybersecurity
How safe is DICOM in the wild? As you develop your medical imaging device or service, prepare for the standards and regulations protecting hospital networks from ransomware.
ArticleCybersecurity
A short article that attempts to explain why badly made diagrams will confuse FDA reviewers and slow down your submissions. Includes links to the relevant guidance and a few bes...
J. David Giese
ArticleCybersecurity
This is a redline between the 2022 Draft cybersecurity guidance and the final 2023 cybersecurity guidance. It should be useful to medical-device regulatory professionals who wan...
J. David Giese & Meri Martinez
VideoCybersecurity
Security vulnerabilities in medical devices can have devestating consequences. They can lead to patient injuries and in the worst cases, death. In our first public 10x talk, lea...
GuidanceCybersecurity
The FDA guidance discussing risks and documentation for pre-market submissions when devices must inter-operate with other devices (e.g., via DICOM or other standards).
GuidanceCybersecurity
This FDA guidance outlines recommendations for managing cybersecurity vulnerabilities in medical devices, including a risk-based framework for assessing when changes to devices ...
GuidanceCybersecurity
This FDA guidance outlines how manufacturers should maintain the cybersecurity of medical devices that use off-the-shelf software. The guidance provides general principles for s...
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