Every article in our archive in Fundamentals.
Showing 12 of 60 articles in Fundamentals · Page 1 of 5
Security testing for medical devices is not one thing. A practical breakdown of SAST, DAST, SCA, fuzz, penetration testing, and threat model validation - and how the FDA expects them to fit together.
Read article
Operational technology and information technology share terminology but operate under fundamentally different constraints. A practical breakdown of the seven differences that matter for medical device manufacturers and FDA submissions.
Read article
Picture a seasoned enterprise CISO handed responsibility for a fleet of connected infusion pumps and networked imaging systems.
Read article
Many MedTech companies end up with the wrong cybersecurity vendor. Not because they don't care about security, and not because good options don't exist.
Read article
Postmarket medical device cybersecurity is a shared responsibility. See how manufacturers & healthcare organizations must collaborate to reduce.
Read article
Learn how ISO 13485, robust QMS, and strong cybersecurity help MedTech innovators avoid FDA rejections, navigate HIPAA vs FDA, and secure SAMD/SIMD.
Read article
Learn the difference between SaMD and SiMD, why it matters for FDA strategy, and how to build secure-by-design medical devices across your product.
Read article
Two major medical device cybersecurity gaps - dispersed responsibility & missing asset inventories - fuel legacy and secondary-market risk.
Read article
Podcast recap: unpacking the FDA's medical cyber device definition - which products qualify, what 524B requires, and how to document compliance.
Read article
Discover the truth behind the top 5 medical device cybersecurity myths and learn how debunking them can drive innovation, safety, and compliance in.
Read article
Cybersecurity is now central to medical device design. Explore FDA rules, quantum threats, and why early security builds trust and speeds approval.
Read article
Updated April 13, 2025 As with any connected device, cyber threats are simply part of the environment. There’s no way to remove all risk.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.
