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QMSR's Wake-Up Call

When FDA's Quality Management System Regulation came into effect in February 2026, many saw it as a routine update. QMS consultant John Wolf sees something bigger — a reckoning for medical device companies that have been coasting on outdated compliance practices for decades.

AI Medical Device Certification

Strong model performance doesn't guarantee regulatory approval for AI-enabled medical devices. As FDA, EU MDR, and EU AI Act expectations evolve, certification success depends on how the entire system is architected, controlled, and governed — not just how well the model performs. Use our self-assessment to identify gaps in your architecture before they become costly certification bottlenecks.<br>

Energy Sector OT Cybersecurity

The old energy cybersecurity perimeter is gone. With millions of distributed energy resources — solar inverters, smart meters, EV chargers — now connected across open protocols, adversaries are exploiting exposed PLCs, abusing remote access credentials, and manipulating operator views at scale. This article examines the 2026 OT threat landscape and what energy operators must do to architect security into grid-edge infrastructure before the next incident.

Dependable AI: Critical Software Contributions Accepted at SAIV 2026 and FLoC 2026

Critical Software announces two research papers accepted at SAIV 2026 and OVERLAY/FLoC 2026, developed within the SONNX working group. The work applies formal methods to eliminate ambiguity in ML model specifications, enable machine-checked verification, and support certification in safety-critical industries such as aerospace, defense, and transportation.<br>

Why IEC 62443 Matters Beyond Compliance

IEC 62443 is becoming more than a compliance requirement for energy organizations. This article explores why its principles of segmentation, secure-by-design engineering, and lifecycle management are now essential for building resilient industrial infrastructure.

IEC 62304 Edition 2: The Biggest Change in 20 Years Is Coming

IEC 62304 Edition 2 is no longer a future concern. With a major scope expansion to health software, AI lifecycle requirements, and cybersecurity in design control, the window to prepare is shorter than most teams realise.

5 Reasons SBOMs Are Now a Core Engineering Requirement

From federal mandates to cybersecurity resilience, Software Bills of Materials are no longer a compliance afterthought. Here are five reasons why SBOMs have become a foundational engineering practice — and what your team needs to know to stay ahead.

NIS2 Compliance for Energy Teams

NIS2 is reshaping cybersecurity in the energy sector by shifting responsibility from reactive compliance to secure-by-design engineering. It places emphasis on operational resilience, supply chain oversight, strict incident reporting timelines, and executive accountability, requiring engineering teams to integrate security into system architecture from the start.