Navigating Medical Device Cybersecurity: Key Takeaways from Our Ask Me Anything WebinarMedical device cybersecurity is evolving rapidly, and regulatory expectations continue to shift as the threat landscape expands. To help…6d ago6d ago
Understanding FDA’s Draft Guidance for Predetermined Change Control Plans (PCCPs) for Medical…The FDA’s August 2024 Draft Guidance for Predetermined Change Control Plans (PCCP) for Medical Devices introduces significant updates to…Mar 28Mar 28
Published inMedcrypt Medical Device Cybersecurity BlogsSecuring the Past to Protect the Future: Cybersecurity Best Practices for Legacy Medical DevicesLegacy medical devices — those that cannot be reasonably protected against modern cybersecurity threats — pose a serious risk to…Mar 19Mar 19
Medical Device Security Strategy for Startups Navigating FDA 510(k) SubmissionsFor startups developing medical devices, achieving FDA clearance through the 510(k) pathway is a significant milestone. However, with…Mar 10Mar 10
Published inMedcrypt Medical Device Cybersecurity BlogsNavigate the FDA Draft Guidance on Artificial Intelligence (AI) and CybersecurityThe FDA’s newly released draft guidance on artificial intelligence (AI) and cybersecurity is the latest milestone in a series of…Mar 7Mar 7
Published inMedcrypt Medical Device Cybersecurity BlogsGot an SBOM — Now What? A Step-by-Step GuideSoftware Bill of Materials (SBOM) management is more than just generating a list of components in your medical device software. The FDA…Feb 21Feb 21
Published inMedcrypt Medical Device Cybersecurity BlogsEnd-of-Life (EOL) and End-of-Support (EOS): A Growing Challenge for Medical Device ManufacturersWith cybersecurity regulations tightening, the FDA now requires Medical Device Manufacturers (MDMs) to include detailed End-of-Life (EOL)…Feb 13Feb 13
Published inMedcrypt Medical Device Cybersecurity BlogsContec CMS8000 Vulnerability CommunicationYesterday, FDA and CISA (Alert Code ICSMA-25–030–01) released a security alert and recall for the Contec Health CMS8000 Patient Monitor…Jan 31Jan 31
Published inMedcrypt Medical Device Cybersecurity BlogsHow to Prepare for FDA’s Likely Cybersecurity Inspection Guide for Medical DevicesThe FDA has historically provided inspection guides across a range of critical areas that affect medical devices, including Quality…Jan 28Jan 28
Securing Connected Medical Devices: Lessons from Recent Network IntrusionsRecent reports have revealed alarming cybersecurity vulnerabilities within U.S. telecommunications networks, with Chinese state-sponsored…Jan 16Jan 16
