Before the ICH Harmonized Tripartite Guideline Q9—“Quality risk management”—was introduced in 2005, the pharmaceutical industry was evolving but lacked a structured, scientific, and systematic approach.

Electronic temperature compensation in gaging has become a valuable tool in improving the accuracy and gage repeatability and reproducibility (GR&R) of gages in harsh manufacturing environments.

In a world where change is the only constant, organizations can no longer afford to be complacent. Keeping up with the pace of technological change is tough, and all business leaders must learn to adapt. It’s no longer enough to react to disruption.

The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals.

Most quality practitioners are familiar with the Taguchi loss function, which contends that the cost of any deviation from the nominal follows a quadratic model.

Design controls are a set of quality practices and procedures used to ensure that a finished device meets its user needs, intended use, and specified requirements.

Many people don’t realize just how long AI has been around in the healthcare industry—and are surprised to find out that it’s something that’s been relied on for 50 years already.

The objective of all improvement projects should be to improve the overall process. Everything else should be secondary to this objective.

This year, the Medical Device Innovation Consortium held an Excellence in Quality Summit where it was promised that participants would receive a “uniq

On Jan. 31, 2024, the U.S.