Cybersecurity Articles & Videos

Medical-device cybersecurity regulations, threat modeling, SBOMs, vulnerability monitoring, and more

Topics

FeaturedArticleAI/ML

Frustrated with Slow AI Adoption? Here’s why.

AI-assisted medical device development is FDA-compliant when done right. The obstacle isn’t regulation. It’s the messy codebase...

Yujan Shrestha

FeaturedArticleCybersecurity

Medical Device Cybersecurity: Best Practices, FAQs, and Examples

This article provides an in-depth exploration of medical device cybersecurity requirements, including best practices and FAQs. ...

J. David Giese &

FeaturedArticleCybersecurity

Medical Device SBOMs: Best Practices, FAQs, and Examples

Practical suggestions and tips for authoring SBOMs for medical devices and for using them to monitor for cybersecurity vulnerab...

J. David Giese

ArticleAI/ML

How to Get Your AI-Generated, Vibe-Coded Medical Device FDA-Cleared

From solo clinicians prototyping algorithms to enterprise teams shipping production software, tools like Cursor, Claude Code, C...

Yujan Shrestha

ArticleCybersecurity

Does FDA Require Software Escrow?

Does FDA require software escrow for SaMD? Not necessarily. Learn when escrow helps manage closed-source vendor risk, plus what...

J. David Giese

GuidanceCybersecurity

2026 FDA Guidance - Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions

The 2026 FDA guidance on medical device cybersecurity, updated to align cybersecurity expectations with the Quality Management ...

ArticleAI/ML

Stop Doing the “Consultant Thing” and Stop Saying “Ideally”

A client called out the “consultant thing”: hiding behind “ideally” instead of recommending a real plan. This piece explains wh...

Yujan Shrestha

ArticleAI/ML

What Your First 510(k) Actually Costs You

Most first-time teams burn over a year overbuilding documentation FDA never asks for. Here is a section-by-section breakdown of...

Yujan Shrestha

ArticleCybersecurity

On Sharing SBOMs

In this article, we share a nuanced approach to avoiding sharing sensitive information in an SBOM.

J. David Giese

VideoCybersecurity

10x Coffee Talk: Threat Modeling and Cybersecurity Risk Management

The conversation between Yujan Shrestha and J. David Giese focuses on making threat modeling more approachable and less intimid...

Yujan Shrestha & J. David Giese

VideoCybersecurity

Coffee Time: Medical Device Cybersecurity Threats

We discuss challenges in medical device cybersecurity, including balancing FDA guidelines with practical hospital and manufactu...

Yujan Shrestha & J. David Giese

ArticleCybersecurity

FDA Cybersecurity Readiness Survey

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 to Avoid 14 Common FDA Cybersecurity Deficiencies

How do you avoid slowing down your FDA marketing submission (510(k), De Novo, or PMA) with cybersecurity problems? This article...

Yujan Shrestha & George Hattub

ArticleCybersecurity

DICOM Part 15 Security and Medical Device Software

A technical exploration and discussion of DICOM Part 15 Security

ArticleCybersecurity

Do You Need DICOM TLS?

How safe is DICOM in the wild? As you develop your medical imaging device or service, prepare for the standards and regulations...

ArticleCybersecurity

Can Your Software Diagrams Slow Down Your FDA Submission?

A short article that attempts to explain why badly made diagrams will confuse FDA reviewers and slow down your submissions. Inc...

J. David Giese

ArticleCybersecurity

2023 Final FDA Cybersecurity Guidance - Redline

This is a redline between the 2022 Draft cybersecurity guidance and the final 2023 cybersecurity guidance. It should be useful ...

J. David Giese & Meri Martinez

GuidanceCybersecurity

2023 FDA Guidance - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

The long-awaited FDA guidance on cybersecurity, touching both on regulatory submissions and quality system considerations.

Imran Shehzad

VideoCybersecurity

Fuzzing, Sanitizers, and Modern Cybersecurity Practices

Security vulnerabilities in medical devices can have devestating consequences. They can lead to patient injuries and in the wor...

Bimba Shrestha

GuidanceCybersecurity

2017 FDA Guidance - Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices

The FDA guidance discussing risks and documentation for pre-market submissions when devices must inter-operate with other devic...

Imran Shehzad

GuidanceCybersecurity

2016 FDA Guidance - Postmarket Management of Cybersecurity in Medical Devices

This FDA guidance outlines recommendations for managing cybersecurity vulnerabilities in medical devices, including a risk-base...

GuidanceCybersecurity

2005 FDA Guidance - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software

This FDA guidance outlines how manufacturers should maintain the cybersecurity of medical devices that use off-the-shelf softwa...

Imran Shehzad

Get To Market Faster

Medtech Insider Insights

Our Medtech tips will help you get safe and effective Medtech software on the market faster. We cover regulatory process, AI/ML, software, cybersecurity, interoperability and more.