FDA
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.
FDA
The new article provides additional clarifications with respect to the development of use-related risk analyses.
FDA
The new article elaborates further on the submission of use-related risk analyses, and also provides certain examples intended to demonstrate the way the regulatory approach described in the guidance should be applied.
Australia
The article overviews the legal framework for medical device systems and procedure packs intended to be marketed and used in Australia.
Australia
The new article describes in detail the key points related to the regulatory requirements applicable to the specific groups of products, namely medical systems and procedure packs.
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