FDA Compliance
During a June 2025 webinar on pragmatic AI applications in healthcare quality management and regulatory affairs, live polling of quality and regulatory professionals revealed that approximately 80% of respondents were actively implementing AI solutions or seriously considering their use in…
During the last couple of decades working in quality, I’ve lost count of how many times I’ve seen the same pattern play out: A strong launch. Tight focus. Great early results. People doing the right things for the right reasons. Controls are followed. Issues are surfaced quickly. Leaders are…
The medical device industry is counting down to an important deadline: On Feb. 2, 2026, the U.S. Food and Drug Administration’s new Quality Management System Regulation (QMSR) formally replaces the Quality System Regulation (QSR).
Although the full text of the QMSR has been…
Increasingly, inspectors for the U.S. Food and Drug Administration (FDA) will evaluate your CMMS provider’s security controls—not just your internal procedures. In a cloud-hosted GxP environment, data doesn’t stop at your firewall; your vendor’s security posture becomes part of your 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,…