FDA Compliance
When you go to a medical appointment, does the doctor look at you while you talk? Or are they busy typing everything you say into a computer? If it’s the latter, you may find that will change soon, thanks to artificial intelligence.
Some doctors’ offices are using AI services to…
Measurement, in its most basic form, is about comparing the thing you want to measure with a reference. To measure the length of a table, you compare it to a tape measure. To measure flour for a birthday cake, you compare it to a measuring cup. Better references mean better measurements.
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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…