FDA Compliance
The digitalization of society during the last decade has created many opportunities for businesses and organizations. But digitalization, combined with a rapidly changing world, has also opened new threats and vulnerabilities that can cause serious damage to businesses. Every day we see…
As we look ahead to 2026, the medtech sector stands at an intersection of regulatory evolution, technological advancement, and operational transformation.
The landscape for quality and regulatory affairs (QARA) professionals continues to shift, driven by emerging AI capabilities,…
In 2025, there’s been a marked increase in FDA warning letters. During the second quarter of 2025 alone, the U.S. Food and Drug Administration (FDA) issued 172 warning letters. A notable enforcement surge occurred in September 2025 when the FDA released 80 warning letters in a single week.…
Here’s something nobody saw coming: The generation most skeptical of AI isn’t the one that doesn’t understand it. It’s the one that understands it best.
Every new technology faces resistance. The internet? A fad. Smartphones? Unnecessary. Social media? A waste of time. But tech…
In the evenings, after patients have left for the day, our research team visits the radiation oncology offices at the University of Colorado Anschutz Medical Campus to talk to medical physicists about how our research can help cancer patients. We also run experiments in their radiation suites.…
At the corner of quality and assembly, design engineers are frequently confronted with unexpected, complex fluid process issues in the prototyping phase. These obstacles are reflected in voice-of-customer sprints and surveys revealing that medical devices companies in particular stall out in the…