FDA Draft Guidance on Section 524B: Documentation
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.
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.
The new article provides additional details regarding specific aspects associated with cyber devices, such as modifications to it.
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.
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...
Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the investigation of reported problems associated with medical devices. The latest version of the document...