In today’s rapidly evolving healthcare landscape, medical device manufacturers face the dual challenge of driving innovation while ensuring regulatory compliance. As connected devices become increasingly prevalent, cybersecurity has become a critical concern in regulatory submission.
The new article provides a detailed overview of certain specific regulatory aspects associated with x-ray devices intended to be marketed and used in the US.
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.
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.
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.
Medical Devices
