DRAP
The new article provides additional clarifications regarding the approaches to be followed when communicating important safety-related information and also outlines special risk minimization measures to be taken by the parties involved.
FDA
The new article further elaborates on the scope of documentation to be provided concerning cybersecurity devices intended to be marketed and used in the US.
FDA
The new article provides additional details regarding specific aspects associated with cyber devices, such as modifications to it.
FDA
The article addresses the aspects related to possible image artifacts and the way they should be treated and also describes the approach to be applied when reporting results.
ISO Standards
This article highlights details of ISO 14971 and its significance in ensuring the safety and quality of medical devices. Table of Contents In the field of medical device development and manufacturing, ensuring the safety and effectiveness of products is of paramount...
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