Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer. While the promise of simplified, less costly validation is ...

In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global enterprises operating under the scrutiny of the FDA, EMA, and other regulatory ...

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 ...