Risk management remains the top reason the US Food and Drug Administration (FDA) investigators cite medical device makers for ...

Explore resources and examples that explain how small firms can perform monitoring procedures, document results, and turn SQMS No. 1 into an executable process. Firms will need to learn from mistakes, ...

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 ...