ISO 27001 Compliance: Checklist & Guide for Biotech & HealthTech Companies
Biotech companies are under pressure to prove strong data security and compliance. This practical ISO 27001 guide and checklist outlines what biotech firms need to know in 2025 — from protecting IP and clinical data to choosing the right auditor and reducing risk.
Kristina Romanenko
Jul 10, 202511 min read
MDR Cybersecurity Compliance: Complete EU MDR/IVDR Compliance Guide & Checklist 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 28, 202512 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 24, 20254 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 21, 202512 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 20, 202517 min read
Why You Shouldn’t Trust “Top 10 Cybersecurity Companies” Lists
Most "Top 10" security lists are marketing fluff. Here’s how vendors game the system, and what smarter buyers should actually look for when choosing a partner.
Demyd Maiornykov
May 3, 20255 min read