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, ...
Firms that perform audits, reviews, or compilations have a little more than four months to implement the new risk-based quality management (QM) standards. The task may feel daunting, but Joe Lynch, ...
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 ...
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