

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


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


HIPAA Compliance Checklist (Self-Assessment Guide)
Simplify HIPAA compliance with our Self-Assessment Guide. Quickly identify gaps, understand key requirements, and take actionable steps to strengthen your data security and meet regulatory standards. Ideal for startups, biotech, healthtech, and healthcare companies.

Kristina Romanenko
May 26 min read


From Startup to Scale-Up: When Biotech Companies Must Take Security & Compliance Seriously
Discover why scaling biotech companies must prioritize security and compliance. Learn when regulatory triggers like HIPAA, GDPR, and FDA guidelines come into play — and how proactive cybersecurity strengthens growth and partnerships.

Kristina Romanenko
Apr 79 min read


Compliance Automation: Silver Bullet for Security or Just a Myth?
Discover the pros and cons of compliance automation, debunk myths, and see who benefits from more efficient, scalable compliance solutions.

Sekurno
Nov 6, 202419 min read


Navigating Cybersecurity Compliance: A Definitive Guide
Master the essentials of cybersecurity compliance with our definitive guide. Learn how to navigate complex frameworks like SOC 2, PCI DSS, NIST, HIPAA, CCPA, GDPR, and ISO 27001, avoid common pitfalls, and build a security program that drives trust and resilience.

Kristina Romanenko
Sep 25, 202413 min read