The PMA process is lengthy and requires extensive scientific review of your device and the clinical evidence regarding its safety and effectiveness. Photo by César Badilla Miranda on Unsplash.
In the United States, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all devices for patients.
An analysis of U.S.
In the dynamic landscape of the life sciences industry, ensuring compliance with good manufacturing practices (GMP) is imperative to guarantee the safety, efficacy, and quality of pharmaceutical products.
Photo by camilo jimenez on Unsplash
In the healthcare sector, precision isn’t just a requirement. It’s a necessity where the margins for error are perilously thin, and the consequences of inaccuracy can be grave.
CORE staff celebrates National Blue & Green Day at their headquarters in Pittsburgh. Credit: CORE.
Medical equipment is a necessary yet substantial investment for any health system.
When we talk about a lack of work-life balance, stress, or burnout, one of the things we’re actually saying to ourselves is that we feel we have no control over the outcome or our future.
FDA product recalls are on the rise in the post-pandemic era. Photo by National Cancer Institute on Unsplash.
The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls.
Michele Gelfand finds inspiration for new projects all around her: taking in the banter in a boardroom, speaking with taxi drivers when traveling, observing the interactions between physicians and nurses during an unexpected trip to the doctor.
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