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...
North America
The article provides additional details regarding the approach to be applied with respect to certain types of medical devices in terms of regulatory flexibility. Table of Contents Introduction The Food and Drug Administration (FDA), a Philippines regulatory agency in...
Uncategorized
Periodic Safety Update Reports (PSURs) are critical documents for medical device and in vitro diagnostic product manufacturers. These reports are a key component of a manufacturer’s post-market surveillance and risk management program, providing ongoing...
EU MDR/IVDR
Medical devices are an integral part of healthcare, and their safety and efficacy are critical to ensure patient well-being. In 2017, the European Parliament and Council adopted the new Medical Devices Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) to...
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