MDR Cybersecurity Compliance: Complete EU MDR/IVDR Guide for Medical Devices
Navigating MDR cybersecurity compliance under the EU’s new medical and in vitro diagnostic regulations can be complex. This in-depth guide helps device manufacturers understand and implement the cybersecurity requirements of EU MDR (2017/745) and IVDR (2017/746) — from secure-by-design principles to post-market surveillance and CE certification. If you're building or selling connected medical devices or software in Europe, this is essential reading.
Kristina Romanenko
May 2812 min read
Is Our DNA in Safe Hands? What the Regeneron Acquisition of 23andMe Means for Security and Privacy
When Regeneron announced its $256 million acquisition of 23andMe, most headlines focused on drug discovery potential. But beneath the surface lies a deeper concern: the fate of 15 million genetic profiles. At Sekurno, we unpack the post-acquisition security risks, Regeneron’s breach history, and why compliance alone isn’t enough to protect the world’s most personal data—your DNA.
Sekurno
May 244 min read
Understanding FDA Regulation and Cybersecurity Guidance for Software-Enabled Medical Devices
Learn how FDA regulation and cybersecurity guidance apply to software-enabled medical devices, from classification and submission to lifecycle risk management
Kristina Romanenko
May 2112 min read
Building a Biotech Threat Model: A Practical Step-by-Step Guide & Example Case Study
Explore a real-world threat modeling example for a genomics platform using MITRE’s playbook, C4 diagrams, and STRIDE. A practical guide for healthtech and biotech security teams
Alex Rozn
May 2011 min read