In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global en ...

Consumer wearable and smartphone devices provide an accessible means to objectively measure physical activity (PA) through step counts. With the increasing proliferation of this technology, consumers, ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

SALT LAKE CITY, Utah– A major validation of protocol efficacy came from the Insurance Standards Organization (ISO) through its national program rating community fire suppression delivery systems. ISO ...

Correspondence to Dr Moritz Schumann, Institute of Cardiovascular Research and Sports Medicine, Department of Molecular and Cellular Sports Medicine, German Sport University Cologne, Koln 50858, ...

As part of the United States Food and Drug Administration's (FDA's) Critical Path Initiative to medical product development (http://www.fda.gov/oc/initiatives ...

The market has opportunities in comprehensive training for computer system validation, particularly in regulated industries. Key areas include mastering FDA regulations, agile vs. waterfall ...

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support future production increases. How does a practical framework for validation, ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...