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Beyond Patching: How to Secure Medical Devices and Meet FDA Compliance Without Changing Code

Beyond Patching: How to Secure Medical Devices and Meet FDA Compliance Without Changing Code

by RunSafe Security | Oct 7, 2025 | Compliance & Regulations, Medical Device, SBOM (Software Bill of Materials)

Key Takeaways: Legacy devices can’t be patched easily, but compensating controls provide alternatives. SBOMs are critical for transparency and accountability. The FDA now mandates secure development and life cycle planning. Cybersecurity and patient safety are...
The 2025 SBOM Minimum Elements: A Turning Point But Embedded Systems Still Risk Being Left Behind

The 2025 SBOM Minimum Elements: A Turning Point But Embedded Systems Still Risk Being Left Behind

by Kelli Schwalm | Sep 18, 2025 | Compliance & Regulations, Embedded Security, SBOM (Software Bill of Materials)

Key Takeaways The 2025 SBOM minimum elements represent significant progress since the 2021 baseline. New fields, such as license, hashes, and generation context, push SBOMs beyond check-the-box compliance. Licensing data closes a critical blind spot in software supply...
What Product Leaders Need to Know About EU CRA, FDA, and Cyber Regulations

What Product Leaders Need to Know About EU CRA, FDA, and Cyber Regulations

by RunSafe Security | Aug 25, 2025 | Compliance & Regulations, Medical Device

EU CRA, FDA, and Cyber Regulations The regulatory landscape for product security has fundamentally shifted. What was once a “nice-to-have” consideration has become mandatory compliance across industries, with cybersecurity now sitting at the center of product...
What Healthcare Buyers Expect from Medical Device Manufacturers: Security Is No Longer Negotiable

What Healthcare Buyers Expect from Medical Device Manufacturers: Security Is No Longer Negotiable

by RunSafe Security | Jun 25, 2025 | Compliance & Regulations, Medical Device, Uncategorized

The healthcare industry has reached a cybersecurity tipping point. While IT has been the primary focus of security efforts to date, RunSafe Security’s 2025 Medical Device Cybersecurity Index found that 22% of healthcare organizations have experienced cyberattacks that...
The EU Cyber Resilience Act (CRA) Exposed: What You Need to Know Now

The EU Cyber Resilience Act (CRA) Exposed: What You Need to Know Now

by RunSafe Security | May 20, 2025 | Compliance & Regulations, Uncategorized

The EU Cyber Resilience Act (CRA) is set to transform the landscape of cybersecurity compliance for manufacturers, developers, and supply chain providers across Europe—and its impact will be felt far beyond the EU’s borders. While the EU CRA won’t be fully enforced...
A Guide to SBOM Requirements Around the Globe

A Guide to SBOM Requirements Around the Globe

by Jeff Numark | Feb 11, 2025 | Compliance & Regulations, SBOM (Software Bill of Materials), Uncategorized

Over the past several years, regulators around the globe have begun issuing Software Bill of Materials (SBOM) requirements and standards in an effort to strengthen software security. SBOMs are a detailed inventory of all the components—open source, proprietary, and...
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Guide to Creating and Utilizing SBOMs
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