Dec 19, 2023
FDA
The new article highlights the aspects related to the way animal studies should be planned and conducted, including the facility selection, as well as keeping animals during the study
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Oct 31, 2023
FDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
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Oct 20, 2023
FDA
The article provides an overview of the new regulation and highlights the key points associated thereto.
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Oct 12, 2023
CDRH
This article highlights the details of the adverse event reporting regulations in the European Union (EU) and the United States (US), their similarities, differences, and their impact on medical device safety. Table of Contents Ensuring the safety and effectiveness of...
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Oct 11, 2023
CDRH
This article highlights the critical differences between FDA registration, clearance, approval, and granting for medical devices, offering essential insights for manufacturers and healthcare professionals navigating the regulatory landscape Table of Contents In the...
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