The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with

The term “risk-based thinking” (RBT) is familiar to those in the quality profession. This familiarity comes in part from its inclusion in ISO 9001:2015, the International Organization for Standardization (ISO) quality management system standard.

In the article, “ANSI’s Role in the Wide World of Standards,” (Quality Digest, March 12, 2019), we looked at where standards originate and how companies a

In the world of risk management, maintenance of mission-critical equipment drives priorities and budgets. It is the ultimate test of proactive maintenance and smart decision making.

As electric cars and trucks appear increasingly on U.S. highways, it raises the question: When will commercially viable electric vehicles take to the skies?

Someone recently asked me why quality failures and safety incidents continue to occur despite organizations communicating their quality and safety visions to the workforce, developing and implementing quality and safety management systems, and campaigning day in and

The AS9100 family of standards has completed very important updates, raising the business management quality bar again for aerospace and defense suppliers and OEMs.

Recently I’ve seen some startling statistics from Gallup and

Almost 70 percent of American mothers with children younger than 18 work for pay, but motherhood remains disruptive for many women’s work lives.

Last month an investigative report revealed that the U.S. Food and Drug Administration (FDA) has millions of “hidden” serious injury and malfunctions reports on medical devices.