TGA Guidance on Excluded Software: Middleware
The new article describes in detail the regulatory approach to be applied with respect to middleware used for healthcare purposes.
The new article describes in detail the regulatory approach to be applied with respect to middleware used for healthcare purposes.
The new article provides additional clarifications regarding the regulatory approach to be followed with respect to the tools intended to be used for the digitalization of paper-based records used in the healthcare sphere.
The new article describes additional aspects related to the regulatory status of the products for electronic healthcare records.
The article highlights the key points associated with the use-related risk analyses to be conducted with respect to various healthcare products intended to be marketed and used in the US.
The new article provides additional clarifications with respect to the development of use-related risk analyses.