FDA Compliance
Articles
The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls.
FDA product recalls are on the rise in the post-pandemic era. There has been a clear upward trend from 2021 through 2023, and medical devices ranked the highest of all…
Read articleMichele 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. The idea for one of her most recent papers was…
Read articleStain-resistant clothing, fast-food wrappers, and extreme weather gear such as certain jackets and pants—these products get many of their desirable features from a class of manufactured chemicals called per- and polyfluoroalkyl substances (PFAS). But there’s a major downside: Researchers have…
Read articleAs U.S. Supreme Court Justice Louis D. Brandeis famously wrote, “Sunlight is said to be the best of disinfectants.”
In the field of quality, internal audits are the equivalent of sunlight. Like spring cleaning, internal audits provide the opportunity to bring process issues into the open…
Read articleAn internal audit can be an overwhelming prospect, especially if you’re new to a company or internal auditing in general.
The MedTech space is huge, and even the standards that are meant to help, like ISO 13485:2016, cover a lot of ground.
So, if you’re part of the audit team in…
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