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Navigating Post-Quantum Cryptography in Medical Device Cybersecurity

Navigating Post-Quantum Cryptography in Medical Device Cybersecurity

As the medical device industry grapples with increasingly stringent cybersecurity regulations, a new and rapidly approaching risk has moved…
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Securing the Past to Protect the Future: Cybersecurity Best Practices for Legacy Medical Devices

Securing the Past to Protect the Future: Cybersecurity Best Practices for Legacy Medical Devices

Legacy medical devices — those that cannot be reasonably protected against modern cybersecurity threats — pose a serious risk to…
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Navigate the FDA Draft Guidance on Artificial Intelligence (AI) and Cybersecurity

Navigate the FDA Draft Guidance on Artificial Intelligence (AI) and Cybersecurity

The FDA’s newly released draft guidance on artificial intelligence (AI) and cybersecurity is the latest milestone in a series of…
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Got an SBOM — Now What? A Step-by-Step Guide

Got an SBOM — Now What? A Step-by-Step Guide

Software Bill of Materials (SBOM) management is more than just generating a list of components in your medical device software. The FDA…
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End-of-Life (EOL) and End-of-Support (EOS): A Growing Challenge for Medical Device Manufacturers

End-of-Life (EOL) and End-of-Support (EOS): A Growing Challenge for Medical Device Manufacturers

With cybersecurity regulations tightening, the FDA now requires Medical Device Manufacturers (MDMs) to include detailed End-of-Life (EOL)…
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Contec CMS8000 Vulnerability Communication

Contec CMS8000 Vulnerability Communication

Yesterday, FDA and CISA (Alert Code ICSMA-25–030–01) released a security alert and recall for the Contec Health CMS8000 Patient Monitor…
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How to Prepare for FDA’s Likely Cybersecurity Inspection Guide for Medical Devices

How to Prepare for FDA’s Likely Cybersecurity Inspection Guide for Medical Devices

The FDA has historically provided inspection guides across a range of critical areas that affect medical devices, including Quality…
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