Resources

Blogs & White Papers

Blogs & White Papers

AnCyR™: First Machine Learning IDS Successfully Ported to Microcontrollers / RTOS

Microcontrollers have advanced to a point where high-speed network connectivity is a common feature.

FDA Medical Device Cybersecurity Requirements: New Mandate & Enforcement Schedule

Cybersecurity of medical devices has been an increasing area of focus by the United States government in recent years.

A Summary of FDA Premarket Submission Documents

Cybersecurity in Medical Devices Practical Advice for Meeting FDA’s Requirements

Webinars

Cybersecurity in Medical Devices – Practical Advice for FDA’s 510(k) Requirements

As the healthcare industry increasingly relies on interconnected medical devices, ensuring their cybersecurity is paramount to safeguard patient safety and data integrity.

A Deep Dive into Secure Product Development Frameworks (SPDF)

In our second webinar in our series of Cybersecurity In Medical Devices: Practical Advice for FDA’s 510(k) Requirements, we tackle the question of what is a SPDF for medical device cybersecurity.

Secure-by-Design: Using Hardware and Software Protection for FDA Compliance

The third in our series on medical device cybersecurity, this webinar explores the “secure-by-design” approach to medical device software development.

Threat Modeling and Risk Assessment: A Step-by-Step Example

Cybersecurity in Medical Devices: Practical Advice for FDA’s 510(k) Requirements

Medical Device Cyber Testing

Cybersecurity in medical devices isn’t just important—it’s mandatory. The FDA now requires rigorous cybersecurity testing for devices, going beyond standard software checks.

8 Mandatory Security Control Categories for Successful Submissions

Navigating FDA submissions is a make-or-break process for your medical device company’s revenue. But today, cybersecurity is a key component in protecting your product on the market.

SPDF and FDA Compliance: Secure Product Development for Medical Devices

Join us as we explore the FDA’s new cybersecurity requirements for medical devices. We’ll break down the latest guidelines, highlighting how they impact product development, regulatory compliance, and long-term device security.

Breaking Down CISA’s Cybersecurity Advisory on Contec Health

🚨 CISA has identified a cybersecurity vulnerability in Contec Health's patient monitoring device, raising important concerns for medical device security. What does this mean for patient safety, healthcare IT teams, and medical device manufacturers?

Security Risk Management for Medical Devices: Strategies for Compliance

As cybersecurity threats evolve, medical device manufacturers must integrate robust security risk management to meet FDA expectations and safeguard patient safety.

Securing the Future: IoT Cybersecurity for Medical Devices

Join us as we explore the FDA’s new cybersecurity requirements for medical devices. We’ll break down the latest guidelines, highlighting how they impact product development, regulatory compliance, and long-term device security.