Photo by National Cancer Institute on Unsplash
The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals.
Photo by Joel Fulgencio on Unsplash
Most quality practitioners are familiar with the Taguchi loss function, which contends that the cost of any deviation from the nominal follows a quadratic model.
Design controls are a set of quality practices and procedures used to ensure that a finished device meets its user needs, intended use, and specified requirements.
AI has been part of healthcare technology for a long time. Image by Nappy on Unsplash
Many people don’t realize just how long AI has been around in the healthcare industry—and are surprised to find out that it’s something that’s been relied on for 50 years already.
The objective of all improvement projects should be to improve the overall process. Everything else should be secondary to this objective.
“Make it a Blockbuster night!” Credit: Sean Davis
This year, the Medical Device Innovation Consortium held an Excellence in Quality Summit where it was promised that participants would receive a “uniq
Right now, the U.S. and Germany have different approaches to defining, or “realizing” as the researchers call it, the kilogram. Here, NIST researcher Darine Haddad looks on as German researcher Beatrice Rodiek places a sphere on NIST’s highly accurate weighing machine, known as the Kibble balance. The goal of the research is to get closer to the same definition using the different methods. Credit: B. Hayes/NIST
In 2018, the world agreed to redefine the kilogram.
Using a single, centralized electronic data capture system helps you stay compliant and eliminates unnecessary regulatory burden. Photo by Olga Guryanova on Unsplash
Ensuring the accuracy and security of clinical data, as well as compliance with good clinical practice (GCP), will in large part determine the success of your study and regulatory submission to the U.S. Food and Drug Administration (FDA).
When a patient comes into a clinic or hospital, healthcare practitioners have all the tools at their disposal to conduct thorough examinations.
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