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The FDA’s 510(k) process for medical devices is doing a lot of rounds in the news lately. This includes the FDA ...
![A Brief Analysis of Medical Device Quality System Enforcement Actions [2015 -2017]](https://emmainternational.com/wp-content/uploads/2018/11/AnalysisOfMedicalDevice_Blog-gap.png)
Every year FDA releases an annual report for Quality system inspections and enforcement action data for the ...
The revision of the Quality System Regulation [QSR] (21CFR 820) which was a priority set in FDA’s Spring unified ...
The digital health software pre-certification program is FDA’s strong footstep in leading the way to support the ...
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