Resources

Blogs & White Papers

Blogs & White Papers

Building an EU CRA Readiness Program: People, Processes, and Products

This report is a comprehensive guide to planning, budgeting, and managing EU CRA conformity across your product portfolio—with a practical six-phase framework.

Download the White Paper

French Supermarket Hack Underscores the Need for the EU CRA

The recent hack on refrigeration units across Europe highlights the need for the EU Cyber Resilience Act.

Why Automation Is Essential to Achieve EU CRA Compliance

Discover how automation streamlines product-level conformity workflows to help manufacturers achieve EU Cyber Resilience Act compliance.

7 Steps to Take Now: How to Address the EU CRA Reporting Requirements

This article will bring you up to speed on EU CRA reporting requirements and outlines 7 steps to identify resources and implement processes so that your organization has a robust process to meet these obligations, not just respond.

TÜV Rheinland and BG Networks announce strategic partnership to accelerate product cybersecurity compliance

TÜV Rheinland North America, a global leader in independent testing, inspection, and certification services, and BG Networks today announced a new strategic partnership. This collaboration will streamline and accelerate cybersecurity compliance, testing, and security implementation for connected device manufacturers worldwide.

EU CRA Frequently Asked Questions (FAQs)

Many companies still have questions about the EU Cyber Resilience Act and whether it applies to their products. We've compiled this new FAQ based on the top 10 questions we're hearing from customers.

Webinars

Streamlining Your Path to Compliance for the EU CRA

The EU Cyber Resilience Act is reshaping cybersecurity requirements for products sold in the European Union. In this webinar, TÜV Rheinland and BG Networks will provide practical guidance to help you assess your products, understand your compliance obligations, and prioritize the steps needed to prepare for the 2027 compliance deadline.

Understanding the EU Cyber Resilience Act

Our on-demand webinar provides a plain-language breakdown of what the regulation requires, who it affects, and how to prioritize your compliance roadmap.

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.

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.

Medical Device Cybersecurity Threat & Risk Scoring

This webinar provides an overview for Medical Device Cybersecurity Threat Modeling and Risk Assessment. Learn about Risk, Threats, Harms and Why is Risk Assessment Important.

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.

Podcasts

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.

Threat Modeling: The Key to Securing Medical Devices

Join us on our bi-weekly podcast for medical device cybersecurity!

Aithra Live Demo: AI-powered Threat Modeling and Risk Assessments forMedical Devices.

Join us for an exclusive webinar introducing Aithra, a cutting-edge AI-powered tool designed to revolutionize Threat Modeling and Risk Assessments for medical devices.

Is Signal Really Secure? What SignalGate Teaches Us About Cybersecurity

Is the Signal app truly secure? What lessons can we apply from SignalGate to ensure our communications, software and endpoints stay protected?

Third-Party Software Components – SBOM

During this webinar we dive into the real-world challenges of managing third-party software components and Software Bills of Materials (SBOMs).

Threat Modeling – Assets to Consider

As part of our "Securing the Future: IoT Cybersecurity in Medical Devices" LinkedIn Live series, this Thursday’s session dives into “Assets to Consider” in threat modeling.

Threat Scenarios Using the AMPS Example

This session explores real-world cybersecurity risks in connected medical devices through the AMPS case study.

FDA Releases Final Cybersecurity Guidance – What You Need to Know in 20 Min

In our upcoming webinar, BG Networks will provide a time-efficient summary of the differences from the previous version, released in September 2023. We know you're busy so in under 20 minutes, we’ll cover the critical changes and explain how they apply to the security of your medical devices.