FDA
The new article provides extensive clarifications on labeling requirements to be followed in order to ensure all the vitally important information is duly communicated to end-users.
FDA
The new article clarifies the requirements pertaining to the date of manufacture and also highlights the measurement-related matters.
MDCG
The document provides an overview of the EtO regulatory status and highlights the key points to be taken into consideration by the medical device manufacturers utilizing it in their processes.
FDA
The new article addresses FDA guidelines related to models and assembly procedures for diagnostic X-ray equipment, emphasizing unique model identification, assembly responsibilities, and compliance with regulatory standards.
FDA
The new article provides guidance on accidental radiation occurrences (AROs), record-keeping responsibilities, and managing defects in diagnostic x-ray systems.
FDA
The new article further describes the regulatory approach to be applied with respect to X-ray products, explaining the key concepts and ideas.
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