FDA
The new article highlights the aspects related to non-clinical testing considerations related to the devices covered by the scope of the guidance.
FDA
This article highlights 21 CFR part 11, its scope, applicability and effective ways to maintain regulatory compliance. Table of Contents 21 CFR Part 11 is a regulation introduced by the United States Food and Drug Administration (FDA) that sets forth the criteria...
China
In this article, we will provide a comprehensive introduction to Class III medical devices, including what they are, how they are regulated, and what makes them different from other classifications. Whether you are a healthcare professional or simply interested in...
China
The new article describes in detail the approach to be applied with respect to documentation related to informed consent. Table of Contents Class II medical devices are an important segment of the medical device industry.These moderate-risk devices include many...
FDA
The new article addresses aspects related to submission issue requests as a specific type of submission under the Q-Submission program. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
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