As an executive, I've seen how electronic quality management systems (eQMS) revolutionize businesses. eQMS are sophisticated software tools that help companies ensure their products or services meet ...

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

According to FDA, medical devices are distinguished from other discretely manufactured products because devices are “intended to affect the structure or any function of the body of man.” 1 By contrast ...

Quality management systems are really just about one thing: quality. But assuring quality in your products and services has a nice ripple effect of increasing customer satisfaction and keeping them ...

Honey is an amazing creation. For those of us with a sweet tooth, it’s wonderful to watch a swarm of honeybees at work. Of course, the bees are doing much more than making honey—they pollinate roughly ...

Statement on Quality Management Standards No. 1, A Firm’s System of Quality Management, becomes effective on Dec. 15, 2025, and the required documentation surrounding that system’s design, ...

The adoption of a quality management system (QMS) should be a strategic decision of a Nuclear Medicine service. Its design and implementation will be influenced by various factors, for example the ...

A quality management system (QMS) is essential to a safe and efficiently run diagnostic radiology department, providing quality clinical images while maintaining patient and staff radiation doses as ...