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, ...

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, ...

Editor’s note: This article is the first in a series to help practitioners learn about the AICPA’s new quality management standards and prepare to implement them. In June 2022, the AICPA’s Auditing ...

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 ...

The manufacturing industry is more competitive than ever, rewarding forward-thinking manufacturers who successfully accomplish quality, safety and environmental responsibility in their operations.

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 ...