FDA
The new article highlights the aspects related to the updated procedures to be reflected in a Modification Protocol as a part of marketing submission for medical devices utilizing machine learning technology. Table of Contents The Food and Drug Administration (FDA or...
FDA
The new article highlights the aspects related to the general approach to the changes related to software products and also describes the most important concepts used. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
FDA
The new article highlights the aspects related to the key considerations related to the study design. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft...
FDA
A Class 1 medical device is a type of medical device that poses a minimal potential for harm to the user and is generally considered to be low-risk.Class 1 medical devices include a wide range of products, such as bandages, crutches, elastic bandages, and orthopedic...
Uncategorized
A class II medical device is a device that is intended to be used for a moderate-risk purpose. These devices may not pose the same level of risk as class III devices, but they still require some level of regulatory control to ensure their safety and effectiveness....
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